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

Condition(s) studied

Investigational drug(s) / intervention(s)

IQoro: Please refer to arm/group description for information

eXciteosa: Please refer to arm/group description for information

Grouptraining: Please refer to arm/group description for information

Study summary

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.

Eligibility

Primary outcome measure(s)

• Apnea-hypopnea index (AHI) — 90 days. Between first measurement (inclusion in study at baseline) and second measurement (at follow-up after 90 days of intervention or serving as control)
  The primary outcome is the change in the apnea-hypopnea index (AHI) before and after three months of intervention or control. months of training with one of the modalities, according to two overnight ambulatory sleep apnea recordings.

Trial sites (3)

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