The 1 Year Follow-up Objective Oral Appliance Compliance

NCT01533623 | Completed

• 1 other identifier: EC 11/41/291
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will perform a 1-year clinical trial measuring objective compliance during mandibular advancement device (MAD) treatment. The investigators will enroll 50 patients that received treatment with a titratable, duobloc MAD (RespiDent Butterfly®, RespiDent, Nijlen, Belgium) and participated in the original study "Objective versus subjective compliance with oral appliance therapy for obstructive sleep apnea hypopnea syndrome", registered at Clinical Trials.gov (NCT01284881). Active microsensors (TheraMon®,Handelsagentur Gschladt, Hargelsberg, Austria) are provided by the Handelsagentur Gschladt without any costs. The sampling interval of the recording will be done at a rate of 1 measurement per 15 minutes (every 900 seconds). Using this sample interval, the capacity of the active microsensor allows for data acquisition during a 100 day period. A follow-up appointment is scheduled +/- 265 days after the start of the original study. A second follow-up visit is scheduled again 1 year after the start of the original study. The objective measurement of MAD wear time (total hours of wear time and the mean hours of wear per night over the respective period) will be based on the assumption that the MAD has been worn when the chip records a temperature intraorally.

Conditions

Sleep-disordered Breathing

Outcome Measures

Primary Outcomes (1)

• Safety and feasibility of measuring objective mean wearing time

  To assess the safety and feasibility of measuring objective mean wearing time as a measure of objective oral appliance wear. The objective mean wearing time will be assessed using a microsensor thermometer. Regular follow-up visits will be performed, and patients will be questioned regarding side-effects of the microsensor.

  1 year

Secondary Outcomes (1)

• therapeutic index

  1 year

Study Arms (1)

mandibular advancement device treatment

OTHER

Patients diagnosed with sleep-disordered breathing that receive treatment with a titratable, duobloc mandibular advancement devices

Device: Mandibular Advancement Device

Interventions

Mandibular Advancement Device DEVICE

Nightly wearing time

Also known as: RespiDent Butterfly® Mandibular Repositioning Appliance

mandibular advancement device treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• clinical diagnosis of sleep-disordered breathing
• started treatment with a titratable, duobloc mandibular advancement device
• participated in original study 10/48/340 (3 month follow-up of compliance during treatment with mandibular advancement device)

You may not qualify if:

• medical contra-indications for mandibular advancement devices

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (1)

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Interventions

Occlusal Splints

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal Investigator

Study Record Dates

• First Submitted: January 31, 2012
• First Posted: February 15, 2012
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: June 20, 2013

Record last verified: 2013-06

Locations

BE (1)