The use of a boil and bite Mandibular Advancement Device versus a custom Mandibular Advancement Device in Obstructive Sleep Apnea management

Completed

Conditions: obstructief slaapapneu
Obstructive Sleep Apnea
OSA
10046304

Registration Number: NL-OMON48802

Lead Sponsor: OLVG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 58

Inclusion Criteria

* OSA patient confirmed by a PSG
* 18 years and older
* Sufficient understanding of Dutch language in speaking and writing
* Included in DISE study with METc protocol ARB 66070, NL66070.100.18

Exclusion Criteria

Medical and psychological criteria:
* Clear failure or non-acceptance of previous MAD therapy
* Central Sleep Apnea syndrome ( > 50% of central apneas)
* Inability to provided informed consent
* Reversible morphological upper airway abnormalities (e.g. enlarged tonsils),
Dental criteria:
* Extensive periodontal disease or tooth decay (confirmed by Xray).
* Active temporomandibular joint disease (including severe bruxism).
* Restrictions in mouth opening (<25 mm) or advancement of the mandible (<5 mm).
* Partial or complete edentulism (less than 8 teeth in upper or lower jaw).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Polysomnographic parameters (total AHI, supine AHI, non-supine AHI, ODI) </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>OSAsense S18 parameters (ODI)<br /><br>Outcome of Quality of Life questionnaires;<br /><br>- Epworth Sleepiness Scale<br /><br>- Functional Outcome of Sleep Questionnaire<br /><br>- Short Form Health Survey<br /><br>Mandibular advancement<br /><br>Compliance and treatment satisfactionAdverse Events</p><br>