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Long Term Oral Appliance Therapy Effectiveness for Obstructive Sleep Apnea Syndrome

StatusUnknown
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 23, 2024 (before its estimated September 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Jan 2024); last known: Recruiting
  2. Re-verified, no change to tracked fieldsv6
  3. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Sep 2022 to Sep 2026
    • Start date changed from estimate of Aug 1, 2017 to Apr 1, 2018
    • Study sites: 0 to 1
    v5
  4. Start date: Jun 2016 to Aug 1, 2017v4
  5. Start date: Jan 2016 to Jun 2016v3
  6. Start date: Sep 2015 to Jan 2016v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Obstructive sleep apnea (OSA) is a highly prevalent breathing problem that occurs during sleep. OSA have been associated with the obesity epidemic in developing countries; additionally, high OSA prevalence rates are present in populations with cardiovascular and metabolic disorders. Two OSA treatments are currently available, oral appliance (OA) therapy and continuous positive airway pressure (CPAP). OAs are an underutilized non-surgical treatment and few studies have analyzed their long-term effectiveness for patients with OSA. The purpose of this study is to assess the long-term effectiveness of OA therapy in patients with OSA and to explore any changes on cardiovascular related morbidity and mortality related to this therapy.
Trial Details
NCT Number NCT02410850
Lead Sponsor University of British Columbia
Collaborators: Universiteit Antwerpen, University of Sydney, University Hospital, Angers, University of Groningen, Université de Montréal, Kaiser Permanente, Stanford University, Laval University, University of Cambridge, Kyushu University, Japan Somnology Center, Neuropsychiatric Research Institute, Uniformed Services University of the Health Sciences
Conditions
(from sponsor)		 Obstructive Sleep Apnea
Related terms Sleep Apnea, Obstructive
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov