NCT01284881

Brief Summary

Oral appliances, such as Mandibular Repositioning Appliances (MRA), have emerged as a treatment option for sleep-disordered breathing (SDB). The purpose of this study is to compare active measurement of MRA compliance with patient's self-report.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2010

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

February 2, 2012

Status Verified

January 1, 2012

Enrollment Period

8 months

First QC Date

January 26, 2011

Last Update Submit

January 31, 2012

Conditions

OSAHS

Keywords

MRAcomplianceOSAHS

Study Arms (1)

OSAHS

Device: MRA

Interventions

MRADEVICE

daily wear overnight

OSAHS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

OSAHS

You may qualify if:

  • clinical diagnosis of sleep-disordered breathing
  • started treatment with oral appliances, such as mandibular repositioning appliances

You may not qualify if:

  • medical contra-indications for MRA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antwerp University Hospital

Edegem, 2650, Belgium

Location

Related Publications (2)

  • Dieltjens M, Verbruggen AE, Braem MJ, Wouters K, Verbraecken JA, De Backer WA, Hamans E, Van de Heyning PH, Vanderveken OM. Determinants of Objective Compliance During Oral Appliance Therapy in Patients With Sleep-Disordered Breathing: A Prospective Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2015 Oct;141(10):894-900. doi: 10.1001/jamaoto.2015.1756.

    PMID: 26402736DERIVED

  • Dieltjens M, Braem MJ, Vroegop AVMT, Wouters K, Verbraecken JA, De Backer WA, Van de Heyning PH, Vanderveken OM. Objectively measured vs self-reported compliance during oral appliance therapy for sleep-disordered breathing. Chest. 2013 Nov;144(5):1495-1502. doi: 10.1378/chest.13-0613.

    PMID: 23928873DERIVED

MeSH Terms

Conditions

Sleep Apnea, ObstructivePatient Compliance

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ethical Comité Antwerp

Study Record Dates

First Submitted

January 26, 2011

First Posted

January 27, 2011

Study Start

November 1, 2010

Primary Completion

July 1, 2011

Study Completion

December 1, 2011

Last Updated

February 2, 2012

Record last verified: 2012-01

Locations

BE(1)