Evidence map›Paper›PMID 31116848›Full record

Trial reportSleep2019

The role of sham continuous positive airway pressure as a placebo in controlled trials: Best Apnea Interventions for Research Trial.

Michelle L Reid, Kevin J Gleason, Jessie P Bakker, Rui Wang, Murray A Mittleman, Susan Redline

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Sleep, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01261390 (A Planning Study), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
1.6field-weighted citation impact, top 17% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01261390 nacompletednot on this map

A Planning Study: Sleep Apnea Intervention for Cardiovascular Disease Reduction

TypeinterventionalSponsorBrigham and Women's HospitalRan2011 to 2014Enrolled169ConditionsObstructive Sleep ApneaArmsConservative Medical Therapy (CMT), Sham PAP (Sham), Active PAP with RT Support (Active-Beh), Active PAP with Behavioral Modification (Active+Beh)
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 23 citations in OpenAlex.

  1. Long-term effects on clinical event, mental health, and related outcomes of CPAP for obstructive sleep apnea: a systematic review.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2024
    Pooled it
  2. Trial
  3. The impact of obstructive sleep apnea treatment on microvascular complications in patients with type 2 diabetes: a feasibility randomized controlled trial.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2024
    Trial
  4. Effect of continuous positive airway pressure treatment on ambulatory blood pressures in high-risk sleep apnea patients: a randomized controlled trial.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2022
    Trial
  5. Trial
  6. Article
  7. Article
  8. Review
  9. Article
  10. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 4 institutions in 1 country.

Michelle L ReidDivision of Sleep and Circadian Disorders, Department of Medicine, Brigham and Women's Hospital, Boston MA.
Kevin J GleasonDivision of Sleep and Circadian Disorders, Department of Medicine, Brigham and Women's Hospital, Boston MA.
Jessie P BakkerDivision of Sleep and Circadian Disorders, Department of Medicine, Brigham and Women's Hospital, Boston MA.
Rui WangDivision of Sleep and Circadian Disorders, Department of Medicine, Brigham and Women's Hospital, Boston MA.
Murray A MittlemanDepartment of Epidemiology, Harvard University T.H. Chan School of Public Health, Boston, MA.
Susan RedlineDivision of Sleep and Circadian Disorders, Department of Medicine, Brigham and Women's Hospital, Boston MA.
Harvard University · USBeth Israel Deaconess Medical Center · USChicago Department of Public Health · USCircadian (United States) · US

Funding

Phenotypic and Molecular Signatures for Sleep Apnea and Related MorbiditiesR35HL135818 · NHLBI · BRIGHAM AND WOMEN'S HOSPITAL · PI REDLINE, SUSAN S. · 2017 to 2023
$7.2M
A Planning Study: Sleep Apnea Intervention for Cardiovascular Disease ReductionU34HL105277 · NHLBI · BRIGHAM AND WOMEN'S HOSPITAL · PI MITTLEMAN, MURRAY A, REDLINE, SUSAN S. · 2010 to 2012
$2.5M
NHLBI NIH HHS R35 HL135818NHLBI NIH HHS U34 HL105277
6 · The paper itself

Abstract

STUDY

objectivesThe main objective of this study was to evaluate the role of sham continuous positive airway pressure (CPAP) compared to conservative medical therapy (CMT) as a control arm in the Best Apnea Interventions for Research (BestAIR) study by assessing differences in subjectively and objectively measured outcomes, adverse events, adherence, and retention rates.

methodsBestAIR is a clinical trial aimed to identify important design features for future randomized controlled trials of CPAP. Participants with obstructive sleep apnea were randomized to one of four groups; two control arms (CMT, sham-CPAP) and two active CPAP arms (with and without behavioral interventions). Blood pressure and health-related quality of life outcomes were assessed at baseline, 6 and 12 months. Study outcomes, retention, and adverse event rates were compared between the two control arms. Sham-CPAP adherence and self-efficacy were also compared to active-CPAP adherence (without behavioral intervention).

resultsOur sample included 86 individuals in the control arms and 42 participants in the active-CPAP arm. There were no differences in longitudinal profiles in blood pressure, health-related quality of life outcomes, dropout rates, or adverse events in sham-CPAP group compared to CMT-only group (all ps > 0.05); standardized differences were generally small and with inconsistent directionality across measurements. When compared to active-CPAP, sham-CPAP was associated with 93 fewer minutes/night of usage over 12 months (p = 0.007) and lower outcome expectations (p < 0.05).

conclusionWe observed no evidence of differences in objectively or subjectively measured outcomes with the use of sham-CPAP compared to CMT group. The lower adherence on sham-CPAP and poorer self-efficacy compared to active-CPAP may suggest differences in perceived benefit. REGISTRATION: NCT01261390 Best Apnea Interventions for Research (BestAIR) www.clinicaltrials.gov.

Indexed as

AgedBlood PressureContinuous Positive Airway PressureFemaleHumansMaleMiddle AgedOutcome Assessment, Health CarePatient CompliancePlacebosQuality of LifeSleep Apnea, ObstructivePlacebosadherenceclinical trialCPAPplaceboshamsleep apnea

Identifiers

PMID31116848
PMCPMC7182666
OpenAlexW2945507790

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.