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Dynamic LED-light versus static LED-light for depressed inpatients: study protocol for a randomised clinical study.

ABSTRACT: INTRODUCTION:Retrospective studies conducted in psychiatric inpatient wards have shown a relation between the intensity of daylight in patient rooms and the length of stay, pointing to an antidepressant effect of ambient lighting conditions. Light therapy has shown a promising antidepressant effect when administered from a light box. The emergence of light-emitting diode (LED) technology has made it possible to build luminaires into rooms and to dynamically mimic the spectral and temporal distribution of daylight. The objective of this study is to investigate the antidepressant efficacy of a newly developed dynamic LED-lighting system installed in an inpatient ward. METHODS AND ANALYSIS:In all, 150 inpatients with a major depressive episode, as part of either a major depressive disorder or as part of a bipolar disorder, will be included. The design is a two-arm 1:1 randomised study with a dynamic LED-lighting arm and a static LED-lighting arm, both as add-on to usual treatment in an inpatient psychiatric ward. The primary outcome is the baseline adjusted score on the 6-item Hamilton Depression Rating Scale at week 3. The secondary outcomes are the mean score on the Suicidal Ideation Attributes Scale at week 3, the mean score on the 17-item Hamilton Depression Rating Scale at week 3 and the mean score on the World Health Organisation Quality of Life-BREF (WHOQOL-BREF) at week 3. The spectral distribution of daylight and LED-light, with a specific focus on light mediated through the intrinsically photosensitive retinal ganglion cells, will be measured. Use of light luminaires will be logged. Assessors of Hamilton Depression Rating Scale scores and data analysts will be blinded for treatment allocation. The study was initiated in May 2019 and will end in December 2021. ETHICS AND DISSEMINATION:No ethical issues are expected. Results will be published in peer-reviewed journals, disseminated electronically and in print and presented at symposia. TRIAL REGISTRATION NUMBER:NCT03821506; Pre-results.

SUBMITTER: Volf C

PROVIDER: S-EPMC7045110 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Dynamic LED-light versus static LED-light for depressed inpatients: study protocol for a randomised clinical study.

Volf Carlo C Aggestrup Anne Sofie AS Petersen Paul Michael PM Dam-Hansen Carsten C Knorr Ulla U Petersen Ema Erkocevic EE Engstrøm Janus J Jakobsen Janus C JC Hansen Torben Skov TS Madsen Helle Østergaard HØ Hageman Ida I Martiny Klaus K

BMJ open 20200126 1

<h4>Introduction</h4>Retrospective studies conducted in psychiatric inpatient wards have shown a relation between the intensity of daylight in patient rooms and the length of stay, pointing to an antidepressant effect of ambient lighting conditions. Light therapy has shown a promising antidepressant effect when administered from a light box. The emergence of light-emitting diode (LED) technology has made it possible to build luminaires into rooms and to dynamically mimic the spectral and tempora ...[more]

PMID: 31988225

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Project description:BackgroundRetrospective studies conducted in psychiatric wards have indicated a shorter duration of stay for depressed inpatients in bright compared to dim daylight-exposed rooms, pointing to a possible antidepressant effect of daylight conditions. Dynamic LED lighting, aiming to mimic daylight conditions, are currently been installed in several hospitals, but their feasibility is poorly investigated.MethodsTo investigate the feasibility of these systems, we developed and installed a LED-lighting system in four rooms in a psychiatric inpatient ward. The system could function statically or dynamically regarding light intensity and colour temperature. The system consisted of (A) a large LED luminaire built into the window jamb mimicking sunlight reflections, (B) two LED light luminaires in the ceiling and (C) a LED reading luminaire. In the static mode, the systems provided constant light from A and B. In the dynamic mode, the system changed light intensity and colour temperature using A, B and C. Patients with unipolar or bipolar depression were randomised to dynamic or static LED lighting for 4 weeks, in addition to standard treatment. Primary outcome was the rate of patients discontinuing the trial due to discomfort from the lighting condition. Secondary outcomes were recruitment and dropout rates, visual comfort, depressive symptoms and suicidal ideation.ResultsNo participants discontinued due to discomfort from the LED lighting. Recruitment rate was 39.8%, dropout from treatment rates were 56.3% in the dynamic group and 33.3% in the static group. 78.1% in the dynamic group were satisfied with the lighting compared with 71.8% in the static group. Discomfort from the light (glare) was reported by 11.5% in the dynamic group compared to 5.1% in the static group. Endpoint suicidal scores were 16.8 (10.4) in the dynamic and 16.3 (14.9) in the static group. The lighting system was 100% functional. The light sensor system proved unstable.ConclusionDropout from treatment was high primarily due to early discharge and with a lack of endpoint assessments. The feasibility study has influenced an upcoming large-scale dynamic lighting efficacy trial where we will use a shorter study period of 3 weeks and with more emphasis on endpoint assessments. The lighting was well tolerated in both groups, but some found intensity too low in the evening. Thus, we will use higher intensity blue-enriched light in the morning and higher intensity amber (blue-depleted) light in the evening in the upcoming study. The light sensor system needs to be improved.Trial registrationClinicalTrials.gov: NCT03363529.

Project description:IntroductionCurrent antibiotic prescription for acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is generally based on the Anthonisen criteria in The Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) guideline that have a potential risk of antibiotics overuse. The dilemma is to identify patients who are most likely to benefit from antibiotics while avoiding unnecessary antibiotic use. Procalcitonin (PCT), a more sensitive and specific biomarker of bacterial infection than other conventional laboratory tests, has the potential to determine those patients in whom antibiotics would be beneficial. It is unclear whether PCT-guided antibiotic therapy is safe and effective for patients hospitalised with AECOPD. The study hypothesis is that PCT-guided antibiotic therapy could reduce the antibiotic prescription rate for AECOPD, compared with the GOLD guideline recommendations, without negatively impacting the treatment success rate.Methods and analysisIn this multicenter, open-label, randomised controlled trial, we aim to enrol 500 hospitalised patients with AECOPD that will be randomly assigned to either a PCT-guided group or a GOLD guideline-guided group. The coprimary endpoints are antibiotic prescription rate for AECOPD within 30 days post randomisation and treatment success rate at day 30 post randomisation. The secondary outcomes include: antibiotic prescription rate at day 1 post randomisation; hospital antibiotic exposure; length of hospital stay; rate of subsequent exacerbation and hospital readmission; overall mortality within 30 days post randomisation; changes in lung function and the score of COPD assessment test and modified Medical Research Council; and rate of intensive care unit admission.Ethics and disseminationThis trial has been approved by the ethic committee of China-Japan Friendship Hospital. The findings of the study will be disseminated in peer-reviewed journals. If the results of the study are positive, PCT-guided antibiotic therapy is likely to change the guidelines for antibiotic recommendations for patients with AECOPD.Trial registration numberClinicalTrials.gov: NCT04682899.

Project description:BackgroundThe redislocation rate of conservatively treated patella instability is high. One of the leading surgical strategies is medial patellofemoral ligament reconstruction. Over-tensioning is one of the most challenging complications in static medial patellofemoral ligament reconstruction as the graft used for reconstruction is isometric and the anatomical MPFL is a mostly dynamic structure. As an alternative to established static reconstruction techniques, dynamic graft techniques have been introduced for stabilizing the patella with the aim of providing a more physiological reconstruction of the medial patellofemoral ligament. To date, data on clinical outcomes are scarce and on biomechanical outcomes of the dynamic MPFL reconstruction are lacking. Here, we present the protocol of a randomized clinical trial for comparing clinical and biomechanical outcomes of dynamic versus static medial patellofemoral ligament reconstruction.MethodsThis study is a prospective, single blinded, randomized, multicenter, multimodal (clinical and biomechanical) clinical trial. Patients with recurrent patella dislocation requiring isolated MPFL reconstruction will be recruited and randomized to the dynamic or static reconstruction technique. Participants will be followed up for 2 years with a total of five follow-ups. Preoperative magnetic resonance imaging, upright radiographs, surgical reports and patient records will be evaluated, and clinical and functional outcomes will be measured. Patient-reported knee function and anterior knee pain as assessed with the Kujala score will serve as primary outcome. For biomechanical outcome, pre- and postoperative evaluations will be performed to assess isokinetic muscle strength, gait asymmetry, joint kinematics and kinetics, and timing of muscle activity.DiscussionThe results of the study will clarify whether the reported surgery success for patella stabilization via dynamic MPFL reconstruction is due to muscle contraction or to the passive tenodesis effect combined with clinical outcome measures. With this study, we will provide much needed information on knee biomechanics after dynamic versus static MPFL reconstruction to provide evidence to support orthopedic surgeons in evidence-based decision-making in their quest for surgical techniques most favorable for their patients. Trial registration The study protocol was registered at clinicaltrials.gov (NCT04849130). Registered 19 April 2021, https://clinicaltrials.gov/ct2/show/NCT04849130 .

Dataset Information

Dynamic LED-light versus static LED-light for depressed inpatients: study protocol for a randomised clinical study.

Publications

Dynamic LED-light versus static LED-light for depressed inpatients: study protocol for a randomised clinical study.

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