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Different Forms of OMT as Methods for Reducing Snoring and Mild to Moderate Sleep Apnea

Study acronym: SNORT
StatusEnrolling by Invitation
PhaseNot applicable
Started
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Record status
This record was last updated January 29, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Notable Primary completion date: Mar 28, 2025 to Dec 31, 2025v3 Show 4 more changesShow less
    • Primary endpoint revised
    • Study completion date: Mar 28, 2025 to Jun 30, 2026
    • Secondary endpoints revised (3)
    • Study description revised
  2. Minor Start date changed from estimate of Mar 29, 2024 to May 1, 2024
    • Study description shortened, about 9 words
    v2
  3. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Objective the present project aims to assess the impact of 1) oral screen training, group training, and the use of neuromuscular electrical training (NMES) as orofacial myofunctional therapy (OMT) methods for reducing the apnea-hypopnea index (AHI) among adults with mild to moderate sleep apnea and 2) if these different training methods can reduce snoring and affect the level of sleepiness and quality of life. Study design The study will use a prospective randomized open-blinded endpoint (PROBE) design with baseline measurements, intervention phase, and follow-up measurements. Methods 141 consecutive adult subjects, 71 men and 70 women referred to hospital, due to symptoms of snoring and mild to moderate sleep apnea will be randomized, included, and examined at three different sites, Umeå(Sweden), Lund(Sweden) and Köge(Denmark) One hundred-five of them, 35 in each treatment group, will receive one of the three different forms of training and the final 36 persons serving as controls, age/AHI matched (18 in Köge resp Umeå). Participants in Umeå will be randomized to either training with IQoro® or serving as controls. Participants in Köge will be randomized to either training with Exciteosa®, group training, or controls. The primary outcome is a change in AHI before and after three months of training with the different methods according to overnight ambulatory sleep apnea recordings. The secondary outcomes are change in snoring frequency, sound level dB (A) according to a questionnaire, the Basic Nordic Sleep Questionnaire (BNSQ), daytime sleepiness using the Epworth Sleepiness Scale (ESS), change in quality of life using the short form -36 (SF-36) and muscle strength in tongue before and after treatment.
Trial Details
NCT Number NCT06330116
Lead Sponsor Region Västerbotten
Collaborators: Interreg, Umeå University
Conditions
(from sponsor)
Sleep Apnea, Obstructive, Snoring
Related terms Sleep Apnea, Obstructive, Snoring
Enrollment 141 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov