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Registry Study on Prescription, Patient Pathways, Therapy Efficacy and Usage of Mandibular Advancement Devices in Obstructive Sleep Apnea - PATT-OSA Registry

Study acronym: PATT-OSA
StatusActive, Not Recruiting
PhaseNot specified
SponsorResMed
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 5 months later May 31, 2025 → Oct 31, 2026
See other at-risk trials from ResMed

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from May 31, 2025 to Oct 31, 2026
    • Enrollment closed, study ongoing
    • Study completion pushed from Jun 30, 2025 to Dec 31, 2026
    • Site details revised at 4 of 4 sites
    v8
  2. Re-verified, no change to tracked fieldsv7
  3. Trial status: Not Yet Recruiting to Recruitingv6 Show 4 more changesShow less
    • Primary completion date: Oct 31, 2024 to May 31, 2025
    • Start date changed from estimate of Oct 1, 2023 to Feb 1, 2024
    • Study completion date: Dec 31, 2024 to Jun 30, 2025
    • Site details revised at 4 of 4 sites
  4. Trial status: Suspended to Not Yet Recruitingv5 Show 8 more changesShow less
    • Enrollment target: 250 to 500
    • Primary completion date: Jul 31, 2023 to Oct 31, 2024
    • Start date: May 27, 2020 to Oct 1, 2023
    • Study sites: 1 to 4
    • Study completion date: Aug 31, 2023 to Dec 31, 2024
    • Secondary endpoints revised (10)
    • Study title expanded, about 6 words
    • Eligibility criteria shortened, about 2 words
  5. Trial status: Recruiting to Suspended Sponsor's reason: Study design needs be adapted
    • Primary completion date: Dec 31, 2021 to Jul 31, 2023
    • Study completion date: Mar 31, 2022 to Aug 31, 2023
    • Site details revised
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 1, 2020 to May 27, 2020
    • Study site revised
    v3
  2. Primary completion date: Nov 30, 2020 to Dec 31, 2021
    • Start date: Jul 1, 2019 to May 1, 2020
    • Study completion date: Jan 31, 2021 to Mar 31, 2022
    • Secondary endpoints revised (10)
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
ResMed
18 trials monitored
See 2 trials at risk
During sleep, the muscle tonus in the oropharyngeal space is lost, the tongue might fall back andthe volume of the pharynx decreases. Air cannot pass through as it would in the awake state and thus airflow limitations occur. The person asleep might compensate the flow limitation by breathing faster, which causes the soft tissue to vibrate (= snoring). Further narrowing of the airways can lead to obstructive apneas (complete airway collapse and stopping of airflow). First line therapy for obstructive sleep apnea (OSA) is positive airway pressure (PAP) that keeps the airways open with a pneumatic splint. Since PAP involves wearing a facial mask that applies air pressure into the airways, some patients cannot tolerate this therapy. These patients might be candidates for an alternative treatment approach with a mandibular advancement device (MAD).
Trial Details
NCT Number NCT03924817
Lead Sponsor ResMed
Conditions
(from sponsor)		 Obstructive Sleep Apnea
Related terms Sleep Apnea, Obstructive
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov