Oral Appliances With and Without Elastic Bands to Treat Obstructive Sleep Apnea: A Randomized Crossover Trial
Key facts
- Who runs it
- University of Bergen
- Where
- Norway1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 69 people enrolled
- Started
- 15 Apr 2023
- Ended
- 3 Mar 2024
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Oral appliance with elastic bands
- Oral appliance without elastic bands
- Record updated
- 9 May 2024
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- 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
Who cannot take part
- Considered for treatment with Narval CC (first line oral appliance)
- Mild OSA or no OSA
- 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
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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:
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* 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.
The 2 groups in the trial
- Oral appliance with elastic bandsTreatment being tested
Oral appliance therapy with elastic bands.
- Oral appliance without elastic bandsExisting treatment, for comparison
Oral appliance therapy without elastic bands.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 9 May 2024