Literature DB >> 21344041

Ethical issues in the conduct of clinical trials in obstructive sleep apnea.

Devin L Brown1, Craig S Anderson, Ronald D Chervin, Clete A Kushida, Daniel S Lewin, Beth A Malow, Susan Redline, Edward B Goldman.   

Abstract

Scientifically rigorous clinical trials are needed to test continuous positive airway pressure's (CPAP) effect on important clinical endpoints known to be associated with obstructive sleep apnea, such as myocardial infarction, cardiac arrhythmias, stroke, mortality, seizures, and cognitive function. In this "Special Article," we review the regulatory and ethical issues that surround the design and conduct of CPAP trials, including selection of the appropriate control condition, exclusion criteria, and follow-up duration.

Entities:  

Keywords:  Obstructive sleep apnea; clinical trials; ethics

Mesh：

Year:  2011        PMID： 21344041      PMCID： PMC3041615     

Source DB:  PubMed          Journal:  J Clin Sleep Med        ISSN： 1550-9389            Impact factor:   4.062


  28 in total

1.  What makes clinical research ethical?

Authors:  E J Emanuel; D Wendler; C Grady
Journal:  JAMA       Date:  2000 May 24-31       Impact factor: 56.272

2.  International ethical guidelines for biomedical research involving human subjects.

Authors: 
Journal:  Bull Med Ethics       Date:  2002-10

3.  Effect of continuous positive airway pressure vs placebo continuous positive airway pressure on sleep quality in obstructive sleep apnea.

Authors:  J S Loredo; S Ancoli-Israel; J E Dimsdale
Journal:  Chest       Date:  1999-12       Impact factor: 9.410

4.  Evaluation of sham-CPAP as a placebo in CPAP intervention studies.

Authors:  George W Rodway; Terri E Weaver; Cristina Mancini; Jacqueline Cater; Greg Maislin; Bethany Staley; Kathleen A Ferguson; Charles F P George; David A Schulman; Harly Greenberg; David M Rapoport; Joyce A Walsleben; Teofilo Lee-Chiong; Samuel T Kuna
Journal:  Sleep       Date:  2010-02       Impact factor: 5.849

5.  Comparison of therapeutic and subtherapeutic nasal continuous positive airway pressure for obstructive sleep apnoea: a randomised prospective parallel trial.

Authors:  C Jenkinson; R J Davies; R Mullins; J R Stradling
Journal:  Lancet       Date:  1999-06-19       Impact factor: 79.321

6.  Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study.

Authors:  Jose M Marin; Santiago J Carrizo; Eugenio Vicente; Alvar G N Agusti
Journal:  Lancet       Date:  2005 Mar 19-25       Impact factor: 79.321

7.  Impact of continuous positive airway pressure therapy on blood pressure in patients with obstructive sleep apnea hypopnea: a meta-analysis of randomized controlled trials.

Authors:  M Alajmi; A T Mulgrew; J Fox; W Davidson; M Schulzer; E Mak; C F Ryan; J Fleetham; P Choi; N T Ayas
Journal:  Lung       Date:  2007-03-28       Impact factor: 2.584

8.  The Apnea Positive Pressure Long-term Efficacy Study (APPLES): rationale, design, methods, and procedures.

Authors:  Clete A Kushida; Deborah A Nichols; Stuart F Quan; James L Goodwin; David P White; Daniel J Gottlieb; James K Walsh; Paula K Schweitzer; Christian Guilleminault; Richard D Simon; Eileen B Leary; Pamela R Hyde; Tyson H Holmes; Daniel A Bloch; Sylvan Green; Linda K McEvoy; Alan Gevins; William C Dement
Journal:  J Clin Sleep Med       Date:  2006-07-15       Impact factor: 4.062

9.  Treating obstructive sleep apnea in adults with epilepsy: a randomized pilot trial.

Authors:  B A Malow; N Foldvary-Schaefer; B V Vaughn; L M Selwa; R D Chervin; K J Weatherwax; L Wang; Y Song
Journal:  Neurology       Date:  2008-08-19       Impact factor: 9.910

Review 10.  Effect of nocturnal nasal continuous positive airway pressure on blood pressure in obstructive sleep apnea.

Authors:  Lydia A Bazzano; Zia Khan; Kristi Reynolds; Jiang He
Journal:  Hypertension       Date:  2007-06-04       Impact factor: 10.190
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  11 in total

1.  The Childhood Adenotonsillectomy Trial (CHAT): rationale, design, and challenges of a randomized controlled trial evaluating a standard surgical procedure in a pediatric population.

Authors:  Susan Redline; Raouf Amin; Dean Beebe; Ronald D Chervin; Susan L Garetz; Bruno Giordani; Carole L Marcus; Renee H Moore; Carol L Rosen; Raanan Arens; David Gozal; Eliot S Katz; Ronald B Mitchell; Hiren Muzumdar; H G Taylor; Nina Thomas; Susan Ellenberg
Journal:  Sleep       Date:  2011-11-01       Impact factor: 5.849

2.  Depressive Symptoms before and after Treatment of Obstructive Sleep Apnea in Men and Women.

Authors:  Cass Edwards; Sutapa Mukherjee; Laila Simpson; Lyle J Palmer; Osvaldo P Almeida; David R Hillman
Journal:  J Clin Sleep Med       Date:  2015-09-15       Impact factor: 4.062

3.  Wake-up Call to Identify Obstructive Sleep Apnea in Patients with Ischemic Strokes.

Authors:  Madeleine M Grigg-Damberger
Journal:  J Clin Sleep Med       Date:  2016-04-15       Impact factor: 4.062

4.  Sleep for Stroke Management and Recovery Trial (Sleep SMART): Rationale and methods.

Authors:  Devin L Brown; Valerie Durkalski; Jeffrey S Durmer; Joseph P Broderick; Darin B Zahuranec; Deborah A Levine; Craig S Anderson; Dawn M Bravata; H Klar Yaggi; Lewis B Morgenstern; Claudia S Moy; Ronald D Chervin
Journal:  Int J Stroke       Date:  2020-02-04       Impact factor: 5.266

5.  Effect of CPAP, Weight Loss, or CPAP Plus Weight Loss on Central Hemodynamics and Arterial Stiffness.

Authors:  Snigdha Jain; Indira Gurubhagavatula; Raymond Townsend; Samuel T Kuna; Karen Teff; Thomas A Wadden; Jesse Chittams; Alexandra L Hanlon; Greg Maislin; Hassam Saif; Preston Broderick; Zeshan Ahmad; Allan I Pack; Julio A Chirinos
Journal:  Hypertension       Date:  2017-10-16       Impact factor: 10.190

6.  CPAP Adherence Predictors in a Randomized Trial of Moderate-to-Severe OSA Enriched With Women and Minorities.

Authors:  Anna M May; Tarek Gharibeh; Lu Wang; Amanda Hurley; Harneet Walia; Kingman P Strohl; Reena Mehra
Journal:  Chest       Date:  2018-04-21       Impact factor: 9.410

7.  Success in blinding to group assignment with sham-CPAP.

Authors:  Eileen R Chasens; Oliver J Drumheller; Patrick J Strollo
Journal:  Biol Res Nurs       Date:  2012-10-02       Impact factor: 2.522

8.  Evaluating the treatment of obstructive sleep apnea comorbid with insomnia disorder using an incomplete factorial design.

Authors:  Megan R Crawford; Arlener D Turner; James K Wyatt; Louis F Fogg; Jason C Ong
Journal:  Contemp Clin Trials       Date:  2015-12-28       Impact factor: 2.226

9.  CPAP, weight loss, or both for obstructive sleep apnea.

Authors:  Julio A Chirinos; Indira Gurubhagavatula; Karen Teff; Daniel J Rader; Thomas A Wadden; Raymond Townsend; Gary D Foster; Greg Maislin; Hassam Saif; Preston Broderick; Jesse Chittams; Alexandra L Hanlon; Allan I Pack
Journal:  N Engl J Med       Date:  2014-06-12       Impact factor: 91.245

10.  Randomized clinical trials of cardiovascular disease in obstructive sleep apnea: understanding and overcoming bias.

Authors:  Allan I Pack; Ulysses J Magalang; Bhajan Singh; Samuel T Kuna; Brendan T Keenan; Greg Maislin
Journal:  Sleep       Date:  2021-02-12       Impact factor: 5.849
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