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

NCT06330116 | Enrolling By Invitation FDA Device

• 1 other identifier: 2023-05348-01
• Study Type: interventional
• Target: 141
• Locations: 2 countries
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (1)

• Apnea-hypopnea index (AHI)

  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.

  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)

Secondary Outcomes (3)

• Questionnaires

  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)

• Snoring

  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)

• Tounge strength

  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)

Study Arms (3)

Oral screen

ACTIVE COMPARATOR

Strength training of the oral and pharyngeal muscles is performed with an oral screen (OS)(IQoro). The OS is a device that has an effect both on the brain plasticity and a strengthening effect of oral and pharyngeal muscles. (9) The OS is placed pre-dentally behind closed lips. The patient pulls the OS forward in a horizontal direction with strong pressure for 5 to 10 seconds while firmly resisting the pressure with tightened lips. The exercise is repeated three times, with 3 seconds of rest between repetitions, and is performed 3 times per day. Training for 3 months.

Device: IQoro

Neuromuscular electrical training (NMES)

ACTIVE COMPARATOR

Strength training of the oral and pharyngeal muscles is performed by an oral device used for 20 minutes every day (eXciteosa). The device gives electrical pulses to the surrounding tissue, mainly the tongue. Training for 3 months.

Device: eXciteosa

Group training with an occupational therapist

ACTIVE COMPARATOR

Strength training of the oral and pharyngeal muscles is performed in group, led by an occupational therapist. Training for 3 months.

Behavioral: Grouptraining

Interventions

IQoro DEVICE

Please refer to arm/group description for information

Oral screen

eXciteosa DEVICE

Please refer to arm/group description for information

Neuromuscular electrical training (NMES)

Grouptraining BEHAVIORAL

Please refer to arm/group description for information

Group training with an occupational therapist

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women with AHI 10 - 29 seeking for problems with snoring and obstructive sleep apnea, age 18 to 75.

You may not qualify if:

• Subjects with previous surgery of the soft palate, 9 \< AHI \> 29, smokers, New York Heart Association Functional Classification, NYHA ≥ 3. BMI \>34,9.

Sponsors & Collaborators

• Region Västerbotten: lead
• Interreg: collaborator
• Umeå University: collaborator

Study Sites (3)

Zealand University Hospital

Köge, Region Sjælland, 4600, Denmark

Location

Skåne University Hospital

Lund, Skåne County, 22100, Sweden

Location

Region Västerbotten

Umeå, Västerbotten County, 901 85, Sweden

Location

Related Publications (21)

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MeSH Terms

Conditions

Sleep Apnea, Obstructive; Snoring

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Thorbjörn Holmlund, PhD

  Region Västerbotten

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study will use a prospective randomized open-blinded endpoint (PROBE) design with baseline measurements, intervention phase and follow-up measurements, and controls without intervention. The results are then analyzed and blinded to the evaluators.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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 sights, Umeå(Sweden), Lund(Sweden) and Köge(Denmark) One hundred-five of them, 35 in each treatment group, will receive one of the 3 different forms of training and the final 36 persons serving as controls, age/AHI matched (18 in Köge resp Umeå). Patients in Umeå will be randomized to either training with IQoro or serving as controls. Patients in Köge will be randomized to either training with Exciteosa group training, or controls.

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 26, 2024
• Study Start: May 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 29, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1); SE (2)