Oral Appliances With and Without Elastic Bands to Treat Obstructive Sleep Apnea: A Randomized Crossover Trial

NCT05987618 | Completed

• 1 other identifier: REKVEST550079
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized crossover trial is to investigate the effect of elastic bands attached to oral appliances to minimize mouth opening during sleep in obstructive sleep apnea (OSA) patients. The main questions it aims to answer are:

• Are the success rates (\>50% reduction of AHI) of oral appliances with elastic bands superior to oral appliances treatment without elastic bands in treatment of moderate and severe OSA?
• Are there predictors that can identify patients that will benefit from use of elastic bands in oral appliance treatment of OSA?
• Are there predictors that can identify patients that are classified as non-responders to oral appliance treatment in general, both with and without elastic bands? Participants will be treated with oral appliances with and without elastic bands for 3 weeks, in randomized order. At the end of each 3-week period, the effect of the treatment will be investigated with sleep registrations and questionnaires. After the completion of both 3-week periodes, patients will continue using their preferred treatment modality (with or without elastic bands) and the oral appliance will be titrated if suboptimal treatment effect.

Conditions

Sleep Apnea, Obstructive

Keywords

oral appliance; elastic bands

Outcome Measures

Primary Outcomes (1)

• Difference in success (>50% reduction in AHI) of oral appliance treatment with and without elastic bands.

  The objective effect of the treatment will be measured using ambulatory polypgrahic examination (PG) with a type IV device (Nox T3).

  The difference in success is investigated using PG-measures from controls 3 and 6 weeks after treatment start, at the end of the period with 3 weeks of oral appliance treatment with and without elastic bands.

Secondary Outcomes (8)

• Difference in reported compliance with oral appliance treatment with and without elastic bands.

  The difference in reported compliance will be measured using data from controls 3 and 6 weeks after treatment start, at the end of the period with 3 weeks of oral appliance treatment with and without elastic bands.

• Difference in reported side effects with oral appliance treatment with and without elastic bands.

  The difference in reported side effects will be measured using data from controls 3 and 6 weeks after treatment start, at the end of the period with 3 weeks of oral appliance treatment with and without elastic bands.

• Difference in reported symptoms of anxiety and depression following oral appliance treatment with and without elastic bands.

  Symptoms of anxiety and depression following oral appliance treatment will be measured using data from controls 3 and 6 weeks after treatment start, at the end of the period with 3 weeks of oral appliance treatment with and without elastic bands.

• Difference in subjective reported effect of oral appliance treatment with and without elastic bands.

  The difference in subjective effect is investigated using the questionnaires from controls 3 and 6 weeks after treatment start, at the end of the period with 3 weeks of oral appliance treatment with and without elastic bands.

• Difference in reported insomnia and fatigue following oral appliance treatment with and without elastic bands.

  The difference is investigated using the questionnaires from controls 3 and 6 weeks after treatment start, at the end of the period with 3 weeks of oral appliance treatment with and without elastic bands.

Study Arms (2)

Oral appliance with elastic bands

EXPERIMENTAL

Oral appliance therapy with elastic bands.

Device: Oral appliance with elastic bands

Oral appliance without elastic bands

ACTIVE COMPARATOR

Oral appliance therapy without elastic bands.

Device: Oral appliance without elastic bands

Interventions

Oral appliance with elastic bands DEVICE

The elastic bands are attached to hooks on both the upper and lower appliance, and on both sides. The elastic bands will be carefully selected not to interfere with retention of the oral appliance. The strongest elastic bands that do not interfere with retention of the oral appliance will be chosen, probably within the range of 85-170 grams (3/8" - 3/16").

Also known as: Masel Geoshapes elastomerics

Oral appliance with elastic bands

Oral appliance without elastic bands DEVICE

The oral appliance without the elastic bands.

Oral appliance without elastic bands

Eligibility Criteria

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

You may qualify if:

• Moderate or severe OSA
• Non-compliant and/or non-responder to CPAP-treatment
• Considered for treatment with Somnodent Fusion (second line oral appliance - indicated when retention on remaining teeth is insufficient to retain Narval CC)
• Participate in the "Sleep registry" at Center for Sleep Medicine, Haukeland University Hospital

You may not qualify if:

• Mild OSA or no OSA
• Considered for treatment with Narval CC (first line oral appliance)
• Patients with insufficient amount of teeth to retain an oral appliance
• Patients with full denture
• Patients that do not speak and/or read Norwegian language
• Patients that are not competent to give informed consent

Sponsors & Collaborators

• University of Bergen: lead
• Haukeland University Hospital: collaborator

Study Sites (1)

Center of Sleep Medicine, Haukeland University Hospital

Bergen, 5021, Norway

Location

Related Publications (1)

• Opsahl UL, Berge M, Lehmann S, Bjorvatn B, Johansson A. Prediction of non-responders to oral appliance treatment of obstructive sleep apnea: a pilot study. Sleep Breath. 2025 Apr 15;29(2):159. doi: 10.1007/s11325-025-03315-1.

  PMID: 40232353 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Anders Johansson, PhD

  University of Bergen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The technician scoring the sleep recordings investigating the objective effect of oral appliance treatment with or without elastic bands, will be blinded to which treatment modality the patients are using.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: August 14, 2023
• Study Start: April 15, 2023
• Primary Completion: March 3, 2024
• Study Completion: March 3, 2024
• Last Updated: May 9, 2024

Record last verified: 2024-05

Locations

NO (1)