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Efficacy of Additional Titration During Oral Appliance Treatment for Sleep-disordered Breathing.

Primary Purpose

Obstructive Sleep Apnea Syndrome

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Mandibular Advancement Device (MAD)
Sponsored by
University Hospital, Antwerp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years
  • Body Mass Index (BMI) ≤ 35 kg/m²
  • OSAS, as defined by the American Academy of Sleep Medicine Task Force
  • apnea-hypopnea index (AHI) < 50
  • incomplete elimination of apneas and/or hypopnea during therapy with mandibular advancement device in 75% of maximal protrusion

Exclusion Criteria:

  • Other sleep disorders (i.e. parasomnias)
  • Invasive upper airway surgery for sleep-disordered breathing
  • Known genetic disorders with craniofacial and/or upper airway malformations
  • Use of benzodiazepine and/or antidepressants
  • Known history of psychiatric disease
  • Known history of fibromyalgia and/or chronic fatigue syndrome
  • Dental contra-indications: functional restrictions of the temporomandibular joint, insufficient dentition with pathological changes, insufficient retention for MAD use

Sites / Locations

  • Antwerp University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mandibular Advancement Device (MAD)

Arm Description

Mandibular advancement during therapy with a mandibular advancement device (MAD) in 90% of maximal protrusion

Outcomes

Primary Outcome Measures

Polysomnographic efficacy
Polysomnographic re-evaluation of the severity of sleep apnea (apnea/hypopnea index).

Secondary Outcome Measures

Full Information

First Posted
August 14, 2012
Last Updated
January 15, 2021
Sponsor
University Hospital, Antwerp
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1. Study Identification

Unique Protocol Identification Number
NCT01666886
Brief Title
Efficacy of Additional Titration During Oral Appliance Treatment for Sleep-disordered Breathing.
Official Title
Efficacy of Additional Titration During Oral Appliance Treatment for Sleep-disordered Breathing.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
August 2012 (Actual)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Antwerp

4. Oversight

5. Study Description

Brief Summary
In the protocol "Predicting therapeutic outcome of mandibular advancement device treatment in obstructive sleep apnea (PROMAD)", 100 patients with obstructive sleep apnea are included and started MAD treatment at 75% of maximal protrusion. All patients underwent polysomnography with MAD in situ to evaluate the effect of the MAD on severity of sleep apnea. If the results of the polysomnography with MAD are unsuccessful (defined as a reduction in AHI with the MAD in situ of less than 50% compared to baseline), the therapy needs to be adjusted. Finding the most effective protrusion should be a weighted compromise between efficacy and side-effects of MAD therapy. In patients with insufficient results on the polysomnography with the MAD at 75% of maximal protrusion, the MAD will be further adjusted until 90% of the maximal protrusion measured at the follow-up visit after the polysomnography with the MAD. After habituation and adaptation period but within 2 months after the first polysomnography with MAD, a new polysomnography will be performed to assess the effect of the 90% protruded position.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mandibular Advancement Device (MAD)
Arm Type
Experimental
Arm Description
Mandibular advancement during therapy with a mandibular advancement device (MAD) in 90% of maximal protrusion
Intervention Type
Device
Intervention Name(s)
Mandibular Advancement Device (MAD)
Primary Outcome Measure Information:
Title
Polysomnographic efficacy
Description
Polysomnographic re-evaluation of the severity of sleep apnea (apnea/hypopnea index).
Time Frame
3 to 6 months after start of therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years Body Mass Index (BMI) ≤ 35 kg/m² OSAS, as defined by the American Academy of Sleep Medicine Task Force apnea-hypopnea index (AHI) < 50 incomplete elimination of apneas and/or hypopnea during therapy with mandibular advancement device in 75% of maximal protrusion Exclusion Criteria: Other sleep disorders (i.e. parasomnias) Invasive upper airway surgery for sleep-disordered breathing Known genetic disorders with craniofacial and/or upper airway malformations Use of benzodiazepine and/or antidepressants Known history of psychiatric disease Known history of fibromyalgia and/or chronic fatigue syndrome Dental contra-indications: functional restrictions of the temporomandibular joint, insufficient dentition with pathological changes, insufficient retention for MAD use
Facility Information:
Facility Name
Antwerp University Hospital
City
Wilrijk
State/Province
Antwerp
ZIP/Postal Code
2650
Country
Belgium

12. IPD Sharing Statement

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Efficacy of Additional Titration During Oral Appliance Treatment for Sleep-disordered Breathing.

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