Dataset Information

Obstructive sleep apnea hypopnea syndrome: Protocol for the development of a core outcome set.

ABSTRACT: BACKGROUND:Obstructive sleep apnea hypopnea syndrome (OSAHS) is a common, chronic sleep disease. As the incidence of OSAHS increases, it has seriously threatened people's health. There have been an increasing number of clinical trials of OSAHS in recent years. However, the clinical trials of OSAHS have heterogeneous outcomes, surrogate outcomes, subjective outcomes, and composite outcomes, as well as the lack of endpoints or patient perspectives. The best method is to develop a core outcomes sets (COSs) for OSAHS's clinical trials. METHODS:The development of COSs of OSAHS will include 5 stages: RESULTS:: The results of our study will be published in a peer-reviewed journal. DISCUSSION:The development of the COSs of OSAHS will improve the design and operation of OSAHS clinical trials to conform to international standards and ensure the credibility of the outcomes. In addition, this study will involve different stakeholder groups to help ensure that the developed COSs will be suitable and well accepted. TRIAL REGISTRATION NUMBER:1544.

SUBMITTER: Wanyan P

PROVIDER: S-EPMC7447502 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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Obstructive sleep apnea hypopnea syndrome: Protocol for the development of a core outcome set.

Wanyan Pingping P Wang Jianqin J Wang Wenge W Kong Yuke Y Liang Yaojun Y Liu Wei W Yu Qin Q

Medicine 20200801 34

<h4>Background</h4>Obstructive sleep apnea hypopnea syndrome (OSAHS) is a common, chronic sleep disease. As the incidence of OSAHS increases, it has seriously threatened people's health. There have been an increasing number of clinical trials of OSAHS in recent years. However, the clinical trials of OSAHS have heterogeneous outcomes, surrogate outcomes, subjective outcomes, and composite outcomes, as well as the lack of endpoints or patient perspectives. The best method is to develop a core outc ...[more]

PMID: 32846767

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Project description:BackgroundMyofunctional therapy has demonstrated efficacy in treating sleep-disordered breathing. We assessed the clinical use of a new mobile health (mHealth) app that uses a smartphone to teach patients with severe obstructive sleep apnea-hypopnea syndrome (OSAHS) to perform oropharyngeal exercises.ObjectiveWe conducted a pilot randomized trial to evaluate the effects of the app in patients with severe OSAHS.MethodsForty patients with severe OSAHS (apnea-hypoxia index [AHI]>30) were enrolled prospectively and randomized into an intervention group that used the app for 90 sessions or a control group. Anthropometric measures, Epworth Sleepiness Scale (0-24), Pittsburgh Sleep Quality Index (0-21), Iowa Oral Performance Instrument (IOPI) scores, and oxygen desaturation index were measured before and after the intervention.ResultsAfter the intervention, 28 patients remained. No significant changes were observed in the control group; however, the intervention group showed significant improvements in most metrics. AHI decreased by 53.4% from 44.7 (range 33.8-55.6) to 20.88 (14.02-27.7) events/hour (P<.001). The oxygen desaturation index decreased by 46.5% from 36.31 (27.19-43.43) to 19.4 (12.9-25.98) events/hour (P=.003). The IOPI maximum tongue score increased from 39.83 (35.32-45.2) to 59.06 (54.74-64.00) kPa (P<.001), and the IOPI maximum lip score increased from 27.89 (24.16-32.47) to 44.11 (39.5-48.8) kPa (P<.001). The AHI correlated significantly with IOPI tongue and lip improvements (Pearson correlation coefficient -0.56 and -0.46, respectively; both P<.001). The Epworth Sleepiness Scale score decreased from 10.33 (8.71-12.24) to 5.37 (3.45-7.28) in the app group (P<.001), but the Pittsburgh Sleep Quality Index did not change significantly.ConclusionsOrofacial exercises performed using an mHealth app reduced OSAHS severity and symptoms, and represent a promising treatment for OSAHS.Trial registrationSpanish Registry of Clinical Studies AWGAPN-2019-01, ClinicalTrials.gov NCT04438785; https://clinicaltrials.gov/ct2/show/NCT04438785.

Project description:BackgroundPatients with obstructive sleep apnea/hypopnea syndrome (OSAHS), even those generally compliant with CPAP therapy, often intermittently discontinue CPAP.Study objectiveExamine the impact of CPAP withdrawal on sleep, sleep disordered breathing (SDB), and daytime function in subjects with varying severity of OSAHS.Patients and interventionsForty-two subjects (26M/16 F) with OSAHS (AHI4% = 45.2 ± 35.5/h pretreatment) on CPAP for 4 months were evaluated on the second night of CPAP withdrawal. Sleep architecture, SDB indices, and subjective/objective daytime function were assessed pretreatment, on CPAP therapy, and after CPAP withdrawal. Comparisons were made between pretreatment and CPAP withdrawal for the entire group, and for subgroups of mild/moderate (AHI4% < 30/h, n = 22) and severe (AHI4% > 30/h, n = 20) SDB.ResultsOverall, and for mild/moderate subjects, SDB indices returned to pretreatment values on CPAP withdrawal but with fewer apneas and more hypopneas/RERAs. For severe SDB, the event frequency (AI, AHI4%, and RDI) was lower and O2 desaturation was improved on CPAP withdrawal. Across SDB severity, sleep architecture showed lower %REM (15.6% vs 12.9%, P = 0.009) on the CPAP withdrawal compared to pretreatment. Stanford Sleepiness Score, MSLT, and PVT measures were not significantly different between pretreatment and CPAP withdrawal.ConclusionsOver a wide range of SDB severity CPAP withdrawal results in recurrence of SDB, albeit with less severe O2 desaturation. Subjective/objective daytime function returned to pretreatment levels. Sleep architecture changes on CPAP withdrawal (acute SDB) may reflect reduced sleep pressure compared to pretreatment chronic SDB. Our data suggest detrimental effects of even brief withdrawal of CPAP in subjects with both mild and severe OSAHS.CitationYoung LR; Taxin ZH; Norman RG; Walsleben JA; Rapoport DM; Ayappa I. Response to CPAP withdrawal in patients with mild versus severe obstructive sleep apnea/hypopnea syndrome. SLEEP 2013;36(3):405-412.

Dataset Information

Obstructive sleep apnea hypopnea syndrome: Protocol for the development of a core outcome set.

Publications

Obstructive sleep apnea hypopnea syndrome: Protocol for the development of a core outcome set.

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