Het verschil tussen een tijdelijke en een op maat gemaakte uitneembare beugel voor de behandeling van slaapapneu
- Conditions
- Obstructive Sleep ApneaMandibular Advancement Device
- Registration Number
- NL-OMON28622
- Lead Sponsor
- Academic Center Dentistry Amsterdam (ACTA)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 58
Inclusion Criteria
•>18 years of age
•Diagnosis of OSA confirmed by a PSG (AHI ≥ 5)
Exclusion Criteria
Medical and psychological criteria:
•Reversible morphological upper airway abnormalities (e.g. enlarged tonsils)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •PSG parameters: Baseline AHI, AHI after 12 weeks follow-up with either MyTAP or TAP1 (total AHI, supine AHI, non-supine AHI and ODI <br /><br>•WristOx parameters: ODI<br /><br>•DISE outcomes: by using the VOTE classification with and without jaw thrust and MyTAP <br /><br><br /><br>Treatment with MyTAP or TAP1 therapy is listed as successful if the AHI reduction either is <5 or showed a 50% reduction from the baseline AHI, with an AHI of at least <10 per hour in a patient without subjective OSA symptoms while using therapy. <br>
- Secondary Outcome Measures
Name Time Method •Questionnaires: Epworth Sleepiness Scale, Functional Outcomes of Sleep Questionnaire, Short form Survey (RAND36) at baseline, 12 and 25 weeks of follow-up<br /><br>•Mandibular advancement: percentage of maximal protrusion after 12 weeks of treatment with MyTAP and after 12 weeks of treatment with a custom-made MAD <br /><br>•Compliance and treatment satisfaction: therapy use in hours/night and nights/week, therapy evaluation <br /><br>•Adverse Events: possible temporary side effects on short term such as: Hypo or hypersalivation, Sensitive dentition or gums, Sensitive joints or muscles