Can Objective Compliance Monitoring Increase Mandibular Advancement Device Usage in Obstructive Sleep Apnea Patients

Not Applicable

Terminated

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: SomnoDent Flex with DentiTrac

• Registration Number: NCT02885571
• Lead Sponsor: Seoul National University Hospital

Brief Summary

This study evaluates whether objective compliance monitoring can increase mandibular advancement device (MAD) usage in obstructive sleep apnea (OSA) patients. Half of participants will be assigned to objective compliance monitoring group (experimental group), while the other will be assigned to subjective compliance monitoring group (control group). A physician will prescribe and explain to patients based on data from objective or subjective compliance monitoring.

Detailed Description

The design of this study is a randomized controlled trial. Total 40 participants are randomly divided into 2 groups: objective compliance monitoring (n=20) and subjective compliance monitoring (n=20). Both groups wear the same MAD (commercial name: SomnoDent Flex with DentiTrac). They visit Seol National University Hospital at 1, 3, and 6 month after the initiation of MAD. A research coordinator acquires data by downloading from the MAD or by asking the patients, and then transfer the information to the physician. If the patient belongs to objective compliance group, data from the MAD will be transferred to the physician. But if the patient belongs to subjective compliance group, data acquired by asking patients will be transferred to the physician. A physician will prescribe and explain to patients based on data from objective or subjective compliance monitoring.The primary aims is to examine the effectiveness of SomnoDent Flex with DentiTrac, in terms of compliance.

Study Timeline

• Study Start: 2016-04-21
• Study First Submitted: 2016-08-17
• Study First Submitted QC: 2016-08-26
• Study First Posted: 2016-08-31
• Primary Completion: 2017-06-13
• Study Completion: 2017-07-03
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-03
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• obstructive sleep apnea patients without a history of soft palate surgery and moderate to severe periodontal disease.

Exclusion Criteria

• central sleep apnea
• active mandibular disease
• tooth grinding
• moderate to severe periodontal disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MAD for subjective compliance	SomnoDent Flex with DentiTrac	MAD for subjective compliance group wears the same SomnoDent Flex with DentiTrac to objective group, but they are subjected to be prescribed based on the subjective compliance data, which are acquired from patient's explanation. Compliance (average daily time,
MAD for objective compliance	SomnoDent Flex with DentiTrac	MAD for objective compliance group wears the same SomnoDent Flex with DentiTrac to subjective group, but they are subjected to be prescribed based on the objective compliance data, which are acquired from data recorded within SomnoDent Flex with DentiTrac.

Primary Outcome Measures

Name	Time	Method
Average daily use (hours)	one month	The average number of hours the patient wore and did not wear the SomnoDent Flex with DentiTrac for previous one month

Secondary Outcome Measures

Name	Time	Method
Days used for ≥ 15 min	one month	Days the patient wore for ≥ 15 min the SomnoDent Flex with DentiTrac for previous one month
Days used for ≥ 4 hrs	one month	Days the patient wore for ≥ 4 hrs the SomnoDent Flex with DentiTrac for previous one month

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of