Smartphone-based delivery of oropharyngeal exercises for treatment of snoring: a randomized controlled trial.
Ontology highlight
ABSTRACT:
SUBMITTER: Goswami U
PROVIDER: S-EPMC6340784 | biostudies-literature | 2019 Mar
REPOSITORIES: biostudies-literature
Publications
Smartphone-based delivery of oropharyngeal exercises for treatment of snoring: a randomized controlled trial.
Goswami Umesh U Black Adam A Krohn Brian B Meyers Wendy W Iber Conrad C
Sleep & breathing = Schlaf & Atmung 20180721 1
<h4>Purpose</h4>Upper airway exercises for snoring treatment can be effective but difficult to administer and monitor. We hypothesized that a brief, relatively simple daily upper airway exercise regimen, administered by a smartphone application, would reduce snoring and encourage compliance.<h4>Methods</h4>Targeted vowel sounds causing tongue base movements were incorporated into a voice-controlled smartphone game application. Participants with habitual snoring, apnea hypopnea index (AHI) ≤ 14 e ...[more]
Similar Datasets
Project description:BackgroundMinimally invasive surgeries of the soft palate have emerged as a less-invasive treatment for habitual snoring. To date, there is only limited information available comparing the effects of snoring sound between different minimally invasive surgeries in the treatment of habitual snoring.ObjectiveTo compare the efficacy of palatal implant and radiofrequency surgery, in the reduction of snoring through subjective evaluation of snoring and objective snoring sound analysis.Patients and methodThirty patients with habitual snoring due to palatal obstruction (apnea-hypopnea index ?15, body max index ?30) were prospectively enrolled and randomized to undergo a single session of palatal implant or temperature-controlled radiofrequency surgery of the soft palate under local anesthesia. Snoring was primarily evaluated by the patient with a 10 cm visual analogue scale (VAS) at baseline and at a 3-month follow-up visit and the change in VAS was the primary outcome. Moreover, life qualities, measured by snore outcomes survey, and full-night snoring sounds, analyzed by a sound analytic program (Snore Map), were also investigated at the same time.ResultsTwenty-eight patients completed the study; 14 received palatal implant surgery and 14 underwent radiofrequency surgery. The VAS and snore outcomes survey scores were significantly improved in both groups. However, the good response (postoperative VAS ?3 or postoperative VAS ?5 plus snore outcomes survey score ?60) rate of the palatal implant group was significantly higher than that of the radiofrequency group (79% vs. 29%, P?=?0.021). The maximal loudness of low-frequency (40-300 Hz) snores was reduced significantly in the palatal implant group. In addition, the snoring index was significantly reduced in the radiofrequency group.ConclusionsBoth palatal implants and a single-stage radiofrequency surgery improve subjective snoring outcomes, but palatal implants have a greater effect on most measures of subjective and objective snoring. Multi-stage radiofrequency surgery was not tested.Trial registrationClinicalTrials.gov NCT01955083.
| S-EPMC4016275 | biostudies-literature
Project description:A strong and growing body of evidence has demonstrated the effectiveness of cognitive behavioral therapy (CBT), either face-to-face, in person, or as self-help via the Internet, for depression. However, CBT is a complex intervention consisting of several putatively effective components, and how each component may or may not contribute to the overall effectiveness of CBT is poorly understood.The aim of this study was to investigate how the users of smartphone CBT use and benefit from various components of the program.This is a secondary analysis from a 9-week, single-blind, randomized controlled trial that has demonstrated the effectiveness of adjunctive use of smartphone CBT (Kokoro-App) over antidepressant pharmacotherapy alone among patients with drug-resistant major depressive disorder (total n=164, standardized mean difference in depression severity at week 9=0.40, J Med Internet Res). Kokoro-App consists of three cognitive behavioral skills of self-monitoring, behavioral activation, and cognitive restructuring, with corresponding worksheets to fill in. All activities of the participants learning each session of the program and completing each worksheet were uploaded onto Kokoro-Web, which each patient could use for self-check. We examined what use characteristics differentiated the more successful users of the CBT app from the less successful ones, split at the median of change in depression severity.A total of 81 patients with major depression were allocated to the smartphone CBT. On average, they completed 7.0 (standard deviation [SD] 1.4) out of 8 sessions of the program; it took them 10.8 (SD 4.2) days to complete one session, during which they spent 62 min (SD 96) on the app. There were no statistically significant differences in the number of sessions completed, time spent for the program, or the number of completed self-monitoring worksheets between the beneficiaries and the nonbeneficiaries. However, the former completed more behavioral activation tasks, engaged in different types of activities, and also filled in more cognitive restructuring worksheets than the latter. Activities such as "test-drive a new car," "go to a coffee shop after lunch," or "call up an old friend" were found to be particularly rewarding. All cognitive restructuring strategies were found to significantly decrease the distress level, with "What would be your advice to a friend who has a similar problem?" found more helpful than some other strategies.The CBT program offered via smartphone and connected to the remote server is not only effective in alleviating depression but also opens a new avenue in gathering information of what and how each participant may utilize the program. The activities and strategies found useful in this analysis will provide valuable information in brush-ups of the program itself and of mobile health (mHealth) in general.Japanese Clinical Trials Registry UMIN CTR 000013693; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ ctr_view.cgi?recptno=R000015984 (Archived by WebCite at http://www.webcitation.org/6u6pxVwik).
| S-EPMC5785683 | biostudies-other
Project description:BackgroundAvailable smartphone-based interventions for depression predominantly use evidence-based strategies from cognitive-behavioral therapy (CBT), but patient engagement and reported effect sizes are small. Recently, studies have demonstrated that smartphone-based interventions combining CBT with gamified approach-avoidance bias modification training (AAMT) can foster patient engagement and reduce symptoms of several mental health problems.ObjectiveBased on these findings, we developed a gamified smartphone-based intervention, mentalis Phoenix (MT-Phoenix), and hypothesized the program would both engage patients and produce preliminary evidence for the reduction of depressive symptoms.MethodsTo test this hypothesis, we evaluated MT-Phoenix in a randomized controlled pilot trial including 77 individuals with elevated depression scores (Patient Health Questionnaire-9 scores ≥5). Participants were either instructed to train for 14 days with MT-Phoenix or assigned to a waitlist control condition. Engagement with the intervention was measured by assessing usage data. The primary outcome was reduction in depressive symptom severity at postassessment.ResultsData from this pilot trial shows that participants in the intervention group used the smartphone-based intervention for 46% of all days (6.4/14) and reported a significantly greater reduction of depressive symptoms than did participants in the control condition (F1,74=19.34; P=.001), with a large effect size (d=1.02). Effects were sustained at a 3-month follow-up.ConclusionsA gamified smartphone-based intervention combining CBT with AAMT may foster patient engagement and effectively target depressive symptoms. Future studies should evaluate the effectiveness of this intervention in a phase 3 trial using clinical samples. Moreover, the intervention should be compared to active control conditions.Trial registrationGerman Clinical Trial Registry DRKS00012769; https://tinyurl.com/47mw8du7.
| S-EPMC8335612 | biostudies-literature
Project description:BackgroundAntipsychotic medications have limited benefits in schizophrenia, and cognitive behavioral therapy may be beneficial as an adjunct. There may be potential for implementing mobile cognitive behavioral therapy-based treatment for schizophrenia in addition to standard antipsychotic medications.ObjectiveThis study aims to determine whether PEAR-004, a smartphone-based investigational digital therapeutic, improves the symptoms of an acute psychotic exacerbation of schizophrenia when it is added to standard treatments.MethodsThis was a 12-week, multicenter, randomized, sham-controlled, rater-blinded, parallel group proof‑of‑concept study of 112 participants with moderate acute psychotic exacerbation in schizophrenia. This study was conducted in 6 clinical trial research sites in the United States from December 2018 to September 2019. The primary outcome, change in Positive and Negative Syndrome Scale (PANSS) from baseline to week 12 or the last available visit, was analyzed using the mixed-effects regression model for repeated measures, applied to an intent-to-treat sample.ResultsThe total PANSS scores slightly decreased from baseline over the study period in both groups; the treatment difference at day 85 between PEAR-004 and sham was 2.7 points, in favor of the sham (2-sided P=.09). The secondary scales found no benefit, except for transient improvement in depressive symptoms with PEAR-004. Application engagement was good, and patient and clinical investigator satisfaction was high. No safety concerns were observed. There was some evidence of study site heterogeneity for the onboarding processes and directions on PEAR-004 product use at baseline and throughout the study. However, these differences did not affect the efficacy results.ConclusionsIn the largest-to-date randomized, sham-controlled study of a digital therapeutic in schizophrenia, PEAR-004 did not demonstrate an effect on the primary outcome-total PANSS scores-when compared with a nonspecific digital sham control. The secondary and exploratory results also did not demonstrate any notable benefits, except for possible temporary improvement in depressive symptoms. This study provided many useful scientific and operational insights that can be used in the further clinical development of PEAR-004 and other investigational digital therapeutics.Trial registrationClinicalTrials.gov NCT03751280; https://clinicaltrials.gov/ct2/show/NCT03751280.
| S-EPMC9002609 | biostudies-literature
Project description:Introduction: Parkinson's disease (PD) is a common neurodegenerative disease that seriously impairs patients' quality of life, and increases the burden of patients and caregivers. Both drugs and exercise can alleviate its motor and non-motor symptoms, improving the quality of life for PD patients. Telehealth, an increasingly popular tool, makes rehabilitation accessible at home, overcoming the inconvenience of traffic and scheduling. Care-PD is a phone application designed for rehabilitation training, which provides Tai Chi and stretching exercises through tutorial videos as well as an online evaluation system. In this protocol, we will explore the efficacy of Tai Chi and stretching exercises as a PD rehabilitation therapy based on the smartphone application Care-PD. Methods and Analysis: A double-blind, parallel randomized controlled trial will be conducted in this study. The recruitment, intervention, and evaluation processes will be implemented through the Care-PD application. Persons with PD will fill out questionnaires on Activities of Daily Living (ADL), upload the latest case report, and sign the informed consent form in the application. Afterward, doctors and researchers will screen and enroll 180 participants who will be randomly (1:1:1) assigned to Tai Chi group, stretching exercises group, or control group. The subjects will participate in a 1-h exercise session three times per week for 12 weeks, ending with another 4 weeks of follow-up study. Each exercise session includes 10 min of warm-up, 45 min of exercise, and 5 min of cool-down. The primary outcomes are Motor Aspects of Experiences of Daily Living and the 39-item Parkinson's disease Questionnaire. The secondary outcomes include the 9-item Wearing-Off Questionnaire, the Freezing of Gait Questionnaire, the Caregiver Strain Index, Non-motor Experiences of Daily Living, ADL, and Morse Fall Scale. All assessments will be performed at baseline, week 12 and 16. Discussion: Care-PD integrates subject recruitment, intervention, and evaluation, providing a new perspective on clinical rehabilitation for persons with PD. This study will evaluate the efficacy of Tai Chi and stretching exercises on patients' quality of life and disease progression based on a smartphone application. We aim to provide a new rehabilitation training platform for persons with PD. Ethics and Dissemination: This study was approved by the Scientific Research Ethics Committee (102772020RT132) of Shanghai University of Sport. Data collection begins after the approval of the ethics committee. The participants must sign an informed consent form before enrollment. The results will be published in relevant journals, seminars, and be disseminated among rehabilitation practitioners and patients with PD. Clinical Trial Registration: Chinese Clinical Trial Registry, identifier [ChiCTR2100042096]. Registered on January 13, 2021.
| S-EPMC8581180 | biostudies-literature
Project description:ObjectivesHigh levels of dental care-related fear/anxiety, as well as phobia, result in delay or avoidance of dental care, which are associated with poorer oral and overall health. Both pharmacotherapeutic and psychosocial methods are available to treat those with high levels of dental fear/anxiety or phobia, but they are infrequently used and not easily accessed. Smartphones are a potential vehicle for delivering exposure therapy (e.g., a treatment involving systematic encounter with fear-evoking stimuli), but there is a need to test the acceptability of this approach in regard to treatment of high levels of dental anxiety/fear and phobia.MethodsThere were 36 patients with high dental anxiety/fear/phobia randomly assigned to either a treatment or a waitlist condition. Participants completed a pre- and two-week post-multimodal assessment, including a dental behavioral avoidance task. The treatment condition included 2 weeks of self-directed exposure delivered via a personal smartphone in the patients' natural environment.ResultsParticipants in the treatment condition utilized the smartphone exposure an average of 1.6 times daily (SD = 0.85), and found the self-directed exposure highly acceptable. Moreover, they had lower self-reported anxiety and decreased cardiac reactivity at the postassessment compared with the preassessment; no change in anxiety was found for the control condition from pre- to postassessment.ConclusionsHighly anxious, fearful, and dental phobic participants utilized smartphone-delivered exposure therapy, and found it to be an acceptable treatment method. Results support the utility and promise for further testing of the personal smartphone in delivering self-directed exposure therapy for high dental fear/anxiety and phobia.
| S-EPMC7885165 | biostudies-literature
Project description:Antiretroviral therapy can improve the lives of people living with HIV and reduce the rate of transmission. However, high levels of adherence are required. Some people living with HIV, including people who use drugs, are at elevated risk for non-adherence. Contingency management is a promising intervention for promoting adherence to antiretroviral therapy. Barriers to adoption of contingency management include lack of provider expertise and implementation effort. To address these barriers, a smartphone-based adherence intervention was developed. HIV + people with a substance use disorder were required to submit video selfies of medication consumption that met validity criteria. Monetary incentives were delivered to participants via reloadable debit cards, contingent upon a valid video. The intervention was evaluated in a small (n = 50) randomized controlled trial. Intervention participants submitted 75% of possible videos, and 81% of videos met validity criteria, indicating a high level of usability. Participants also rated the intervention as highly acceptable. Adherence was measured as the percent of participants who achieved a 95% adherence threshold, and also as the overall percent of days in which participants were adherent to their antiretroviral therapy. The former showed a significant effect for group, (p = .034) but this was not maintained when adjusting for stratification variables as covariates (p = .094). The latter measure showed a significant group × time interaction. Smartphone-based contingency management is a promising method for promoting adherence to antiretroviral therapy. Assessing the cost-benefit of the intervention and development of strategies for long-term adherence are priorities for future research.
| S-EPMC7815813 | biostudies-literature
Project description:BackgroundDespite potential for benefit, mindfulness remains an emergent area in perinatal mental health care, and evidence of smartphone-based mindfulness training for perinatal depression is especially limited.ObjectiveThe objective of this study was to evaluate the effectiveness of a smartphone-based mindfulness training intervention during pregnancy on perinatal depression and other mental health problems with a randomized controlled design.MethodsPregnant adult women who were potentially at risk of perinatal depression were recruited from an obstetrics clinic and randomized to a self-guided 8-week smartphone-based mindfulness training during pregnancy group or attention control group. Mental health indicators were surveyed over five time points through the postpartum period by online self-assessment. The assessor who collected the follow-up data was blind to the assignment. The primary outcome was depression as measured by symptoms, and secondary outcomes were anxiety, stress, affect, sleep, fatigue, memory, and fear.ResultsA total of 168 participants were randomly allocated to the mindfulness training (n=84) or attention control (n=84) group. The overall dropout rate was 34.5%, and 52.4% of the participants completed the intervention. Mindfulness training participants reported significant improvement of depression (group × time interaction χ24=16.2, P=.003) and secondary outcomes (χ24=13.1, P=.01 for anxiety; χ24=8.4, P=.04 for positive affect) compared to attention control group participants. Medium between-group effect sizes were found on depression and positive affect at postintervention, and on anxiety in late pregnancy (Cohen d=0.47, -0.49, and 0.46, respectively). Mindfulness training participants reported a decreased risk of positive depressive symptom (Edinburgh Postnatal Depression Scale [EPDS] score>9) compared to attention control participants postintervention (odds ratio [OR] 0.391, 95% CI 0.164-0.930) and significantly higher depression symptom remission with different EPDS reduction scores from preintervention to postintervention (OR 3.471-27.986). Parity did not show a significant moderating effect; however, for nulliparous women, mindfulness training participants had significantly improved depression symptoms compared to nulliparous attention control group participants (group × time interaction χ24=18.1, P=.001).ConclusionsSmartphone-based mindfulness training is an effective intervention in improving maternal perinatal depression for those who are potentially at risk of perinatal depression in early pregnancy. Nulliparous women are a promising subgroup who may benefit more from mindfulness training.Trial registrationChinese Clinical Trial Registry ChiCTR1900028521; http://www.chictr.org.cn/showproj.aspx?proj=33474.
| S-EPMC7875700 | biostudies-literature
Project description:BackgroundChronic pain has become a major health problem across the world, especially in older adults. Unfortunately, the effectiveness of medical interventions is modest. Some have argued that assessment strategies should be improved if the impact of medical interventions is to be improved. Ecological momentary assessment using smartphones is now considered the gold standard in monitoring in health settings, including chronic pain. However, to the best of our knowledge, there is no randomized controlled trial to show that telemonitoring using a smartphone app can indeed improve the effectiveness of medical treatments in adults with chronic pain. The goal of this study will be to explore the effects of using a smartphone app for telemonitoring adults with chronic pain.MethodsThe study will be a randomized controlled trial with three groups: treatment as usual (TAU), TAU+app, and TAU+app+alarms. All groups will receive the adequate treatment for their pain, which will be prescribed the first day of study according to clinical guidelines. Assessment in the TAU group will be the usual at the Pain Clinic, that is, a paper-and-pencil evaluation at the onset of treatment (beginning of study) and at follow up (end of study, 30 days later). The other two groups (TAU+app and TAU+app+alarms) will be assessed daily using Pain Monitor, a smartphone app developed by our multidisciplinary team. Telemonitoring will only be made in the TAU+app+alarms group. For this group, physicians at the Pain Clinic may decide to adjust pain treatment in response to alarms. Telemonitoring is not the usual practice at the Pain Clinic and will not occur in the other two groups (TAU and TAU+app), so no changes in treatment are expected in these groups after the first appointment. The total sample size will be 150, with 50 patients in each group. The assessment protocol will be the same in all groups and will include pain intensity and side effects of the medication (primary outcomes), together with several pain-related variables like pain interference, activity level, use of rescue medication, pain catastrophizing, and pain acceptance, among others.DiscussionWe believe that the present trial has important clinical implications. We think that telemonitoring using ecological momentary assessment is crucial to improve current interventions for pain. The armamentarium of available treatments for pain is large, so physicians can turn to different treatments or dosages in the presence of an undesired event. The use of the app for telemonitoring can allow for this rapid detection of unwanted events, thus improving patient safety (i.e., withdrawal of treatment causing side effects) and augmenting treatment effectiveness (i.e., changing an ineffective treatment or dosage). In a time when smartphones are a mainstream technology, we should take advantage of them in the promotion of health care.Trial registrationClinicalTrials.gov, NCT03247725 . Registered on 25 July 2017.
| S-EPMC6389085 | biostudies-literature
Project description:Impairments in social cognition are key determinants of poor functioning in psychosis and an important new target for treatment development. Initial studies support the feasibility and efficacy of training interventions for social cognition, but have been small and have had substantial methodological limitations. This report describes the largest rigorously controlled study of a social cognitive treatment to date. We evaluated the efficacy of a refined version of the 24-session Social Cognitive Skills Training (SCST) program, and whether adding in vivo training sessions in community settings would enhance generalization to functional improvements. One hundred thirty-nine outpatients with psychotic disorders were randomly assigned to one of 3 time- and format-matched conditions: (1) SCST plus in vivo community-based training, (2) SCST plus clinic-based training, or (3) Illness management control condition. SCST targeted the domains of emotion processing, social perception, attributional bias, empathy, and mentalizing. Assessments of social cognition, nonsocial cognition, symptoms, and functioning were completed at baseline, mid-treatment, posttreatment, and 3-month follow-up. On the primary social cognitive outcome measures, there was significant, durable SCST-related improvement in facial emotion identification. There was also a significant SCST benefit for emotional intelligence and an in vivo training effect for empathy, though these improvements were not durable. Further, there were no overall or in vivo-related changes in functioning. This study bolsters and extends support for the efficacy of SCST in a relatively large and rigorously controlled trial, although our effort to enhance generalization to functional improvements through in vivo community-based training was not successful.
| S-EPMC6192506 | biostudies-literature