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NCT03061071

The POSAtive Study: Study for the Treatment of Positional Obstructive Sleep Apnea

Completed NA Last updated 21 August 2018
What this trial tests

NA trial testing NightBalance Sleep Position Trainer (SPT) in Sleep Apnea Syndromes in 117 participants. Completed in 12 July 2018.

Timeline
1 March 2017
Primary endpoint
12 July 2018
12 July 2018

Quick facts

Lead sponsorNightBalance
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingsingle
Primary purposetreatment
Enrollment117
Start date1 March 2017
Primary completion12 July 2018
Estimated completion12 July 2018
Sites11 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

NightBalance

Who can join

Adults 20 to 80, any sex, with Sleep Apnea Syndromes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a prospective, multi-center, randomized crossover of the NightBalance SPT compared to APAP for the treatment of Positional Obstructive Sleep Apnea (POSA).

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Positional therapy for obstructive sleep apnoea.
    Srijithesh PR, Aghoram R, Goel A, Dhanya J. · · 2019 · cited 40× · PMID 31041813 · DOI 10.1002/14651858.cd010990.pub2
  2. NightBalance Sleep Position Treatment Device Versus Auto-Adjusting Positive Airway Pressure for Treatment of Positional Obstructive Sleep Apnea.
    Berry RB, Uhles ML, Abaluck BK, Winslow DH, et al · · 2019 · cited 26× · PMID 31383231 · DOI 10.5664/jcsm.7868
  3. Comparing treatment effects of a convenient vibratory positional device to CPAP in positional OSA: a crossover randomised controlled trial.
    Mok Y, Tan A, Hsu PP, Seow A, et al · · 2020 · cited 19× · PMID 31896735 · DOI 10.1136/thoraxjnl-2019-213547
  4. Sleep Apnea Syndrome (SAS) Clinical Practice Guidelines 2020.
    Akashiba T, Inoue Y, Uchimura N, Ohi M, et al · · 2022 · cited 15× · PMID 38469064 · DOI 10.1007/s41105-021-00353-6

Verify or expand the search:

Other trials of NightBalance Sleep Position Trainer (SPT)

Trials testing the same drug.

Other recruiting trials for Sleep Apnea Syndromes

Currently open trials in the same condition.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03061071.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing