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

NCT05987618 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2024-05-09

No results posted yet for this study

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

Interventions

DEVICE

Oral appliance with elastic bands

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").

DEVICE

Oral appliance without elastic bands

The oral appliance without the elastic bands.

Sponsors & Collaborators

  • Haukeland University Hospital

    collaborator OTHER

  • University of Bergen

    lead OTHER

Principal Investigators

  • Anders Johansson, PhD · University of Bergen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-15
Primary Completion
2024-03-03
Completion
2024-03-03

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05987618 on ClinicalTrials.gov