NCT02885571

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 21, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 31, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2017

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2017

Completed
Last Updated

November 6, 2017

Status Verified

November 1, 2017

Enrollment Period

1.1 years

First QC Date

August 17, 2016

Last Update Submit

November 3, 2017

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • 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

    one month

Secondary Outcomes (2)

  • Days used for ≥ 15 min

    one month

  • Days used for ≥ 4 hrs

    one month

Study Arms (2)

MAD for subjective compliance

ACTIVE COMPARATOR

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,

Device: SomnoDent Flex with DentiTrac

MAD for objective compliance

EXPERIMENTAL

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.

Device: SomnoDent Flex with DentiTrac

Interventions

SomnoDent Flex with DentiTracDEVICE
MAD for objective complianceMAD for subjective compliance

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (3)

  • 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.

    PMID: 23413266BACKGROUND

  • 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.

    PMID: 16494092BACKGROUND

  • 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.

    PMID: 22993169BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Tae-Bin Won, Dr.

    Department of Otorhinolaryngology, Seoul National University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 17, 2016

First Posted

August 31, 2016

Study Start

April 21, 2016

Primary Completion

June 13, 2017

Study Completion

July 3, 2017

Last Updated

November 6, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)