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

NCT02148510 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 313

Last updated 2017-11-08

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Monobloc

Construction fitted to upper and lower jaw

DEVICE

Bibloc

Biblock construction

Sponsors & Collaborators

  • Uppsala University

    lead OTHER

Principal Investigators

  • Goran Isacsson, assoc prof · Västmanlands County hospital Västerås, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2016-05-31
Completion
2017-05-15

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

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 NCT02148510 on ClinicalTrials.gov