NCT02148510

Oral Appliance in Obstructive Sleep Apnea. A Randomized Controlled Blinded Multicenter Study Comparing Two Devices

Oral Appliance in the Treatment of Obstructive Sleep Apnea. A Randomized Controlled Blinded Multicenter Study Comparing the Efficacy of Two Devices

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 313 (actual)
• Sponsor: Uppsala University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The hypothesis of the study is that a bibloc-apnea splint has a comparable efficacy on respiratory measures as a monobloc-apnea splint and that the cost of treatment is the same. The goal is primarily to compare the Apnea-Hypopnea Index (AHI) after 6 weeks of treatment and the cost of treatment during one year. This randomized controlled parallel group multicenter study includes 316 subjects referred for the treatment of moderate to severe Obstructive Sleep Apnea (OSA). The subjects visit the clinic at 5 scheduled occasions.

Detailed description

The study includes 2 arms. Secondary measures are obtained by respiratory analysis and questionnaires. Electromyography (EMG) of the masseter muscle is recorded and the influence of bruxism is evaluated in terms effect on efficacy and adverse events

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	Monobloc	Construction fitted to upper and lower jaw
DEVICE	Bibloc	Biblock construction

Timeline

• Start date: 2014-05-01
• Primary completion: 2016-05-01
• Completion: 2017-05-15
• First posted: 2014-05-28
• Last updated: 2017-11-08

Locations

2 sites across 1 country: Sweden