Can Objective Compliance Monitoring Increase Mandibular Advancement Device Usage in Obstructive Sleep Apnea Patients
Primary Purpose
Obstructive Sleep Apnea
Status
Terminated
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
SomnoDent Flex with DentiTrac
Sponsored by
About this trial
This is an interventional supportive care trial for Obstructive Sleep Apnea
Eligibility Criteria
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
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
MAD for subjective compliance
MAD for objective compliance
Arm Description
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 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.
Outcomes
Primary Outcome Measures
Average daily use (hours)
The average number of hours the patient wore and did not wear the SomnoDent Flex with DentiTrac for previous one month
Secondary Outcome Measures
Days used for ≥ 15 min
Days the patient wore for ≥ 15 min the SomnoDent Flex with DentiTrac for previous one month
Days used for ≥ 4 hrs
Days the patient wore for ≥ 4 hrs the SomnoDent Flex with DentiTrac for previous one month
Full Information
NCT ID
NCT02885571
First Posted
August 17, 2016
Last Updated
November 3, 2017
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02885571
Brief Title
Can Objective Compliance Monitoring Increase Mandibular Advancement Device Usage in Obstructive Sleep Apnea Patients
Official Title
Can Objective Compliance Monitoring Increase Mandibular Advancement Device Usage in Obstructive Sleep Apnea Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Terminated
Why Stopped
Due to suggestions of IRB committee in our institution
Study Start Date
April 21, 2016 (Actual)
Primary Completion Date
June 13, 2017 (Actual)
Study Completion Date
July 3, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MAD for subjective compliance
Arm Type
Active Comparator
Arm Description
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,
Arm Title
MAD for objective compliance
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
SomnoDent Flex with DentiTrac
Primary Outcome Measure Information:
Title
Average daily use (hours)
Description
The average number of hours the patient wore and did not wear the SomnoDent Flex with DentiTrac for previous one month
Time Frame
one month
Secondary Outcome Measure Information:
Title
Days used for ≥ 15 min
Description
Days the patient wore for ≥ 15 min the SomnoDent Flex with DentiTrac for previous one month
Time Frame
one month
Title
Days used for ≥ 4 hrs
Description
Days the patient wore for ≥ 4 hrs the SomnoDent Flex with DentiTrac for previous one month
Time Frame
one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tae-Bin Won, Dr.
Organizational Affiliation
Department of Otorhinolaryngology, Seoul National University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23413266
Citation
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.
Results Reference
background
PubMed Identifier
16494092
Citation
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.
Results Reference
background
PubMed Identifier
22993169
Citation
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.
Results Reference
background
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Can Objective Compliance Monitoring Increase Mandibular Advancement Device Usage in Obstructive Sleep Apnea Patients
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