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

NCT ID: NCT02885571

Last Updated: 2017-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-21

Study Completion Date

2017-07-03

Brief Summary

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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

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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.

Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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MAD for subjective compliance

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,

Group Type ACTIVE_COMPARATOR

SomnoDent Flex with DentiTrac

Intervention Type DEVICE

MAD for objective compliance

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.

Group Type EXPERIMENTAL

SomnoDent Flex with DentiTrac

Intervention Type DEVICE

Interventions

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SomnoDent Flex with DentiTrac

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hyun-Woo Shin

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tae-Bin Won, Dr.

Role: STUDY_CHAIR

Department of Otorhinolaryngology, Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Phillips CL, Grunstein RR, Darendeliler MA, Mihailidou AS, Srinivasan VK, Yee BJ, Marks GB, Cistulli PA. Health outcomes of continuous positive airway pressure versus oral appliance treatment for obstructive sleep apnea: a randomized controlled trial. Am J Respir Crit Care Med. 2013 Apr 15;187(8):879-87. doi: 10.1164/rccm.201212-2223OC.

Reference Type BACKGROUND
PMID: 23413266 (View on PubMed)

Kushida CA, Morgenthaler TI, Littner MR, Alessi CA, Bailey D, Coleman J Jr, Friedman L, Hirshkowitz M, Kapen S, Kramer M, Lee-Chiong T, Owens J, Pancer JP; American Academy of Sleep. Practice parameters for the treatment of snoring and Obstructive Sleep Apnea with oral appliances: an update for 2005. Sleep. 2006 Feb;29(2):240-3. doi: 10.1093/sleep/29.2.240.

Reference Type BACKGROUND
PMID: 16494092 (View on PubMed)

Vanderveken OM, Dieltjens M, Wouters K, De Backer WA, Van de Heyning PH, Braem MJ. Objective measurement of compliance during oral appliance therapy for sleep-disordered breathing. Thorax. 2013 Jan;68(1):91-6. doi: 10.1136/thoraxjnl-2012-201900. Epub 2012 Sep 19.

Reference Type BACKGROUND
PMID: 22993169 (View on PubMed)

Other Identifiers

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D-1510-035-709

Identifier Type: -

Identifier Source: org_study_id