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

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.

Conditions

• Sleep Apnea, Obstructive
• Snoring

Interventions

DEVICE

IQoro

Please refer to arm/group description for information

DEVICE

eXciteosa

Please refer to arm/group description for information

BEHAVIORAL

Grouptraining

Please refer to arm/group description for information

Sponsors & Collaborators

• Interreg

  collaborator OTHER

• Umeå University

  collaborator OTHER

• Region Västerbotten

  lead OTHER_GOV

Principal Investigators

• Thorbjörn Holmlund, PhD · Region Västerbotten

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-05-01

Primary Completion

2025-12-31

Completion

2026-06-30

FDA Device

Yes

Countries

• Denmark
• Sweden

Study Locations