Obstructive Sleep Apnea Mandibular Advancement Device
Conditions
Interventions
54 consecutive OSA patients will be randomized by a cross-over design starting with either the MyTAP or TAP1 therapy. Both interventions are used for a follow-up period of 12 weeks with a washout peri
Sponsors
Academic Center Dentistry Amsterdam (ACTA)
Eligibility
Inclusion criteria
Inclusion criteria: • >18 years of age • Diagnosis of OSA confirmed by a PSG (AHI ≥ 5) • Sufficient understanding of Dutch language in speaking and writing • Sceduled for a DISE and analysed with a boil and bite MAD
Exclusion criteria
Exclusion criteria: Medical and psychological criteria: • Reversible morphological upper airway abnormalities (e.g. enlarged tonsils) • Clear failure or non-acceptance of previous MAD therapy • Central Sleep Apnea syndrome (> 50% of central apneas during diagnostic PSG) • Inability to provided informed consent 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •PSG parameters: Baseline AHI, AHI after 12 weeks follow-up with either MyTAP or TAP1 (total AHI, supine AHI, non-supine AHI and ODI •WristOx parameters: ODI •DISE outcomes: by using the VOTE classification with and without jaw thrust and MyTAP 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Questionnaires: Epworth Sleepiness Scale, Functional Outcomes of Sleep Questionnaire, Short form Survey (RAND36) at baseline, 12 and 25 weeks of follow-up • Mandibular advancement: percentage of maximal protrusion after 12 weeks of treatment with MyTAP and after 12 weeks of treatment with a custom-made MAD • Compliance and treatment satisfaction: therapy use in hours/night and nights/week, therapy evaluation • Adverse Events: possible temporary side effects on short term such as: Hypo or hypersalivation, Sensitive dentition or gums, Sensitive joints or muscles | — |
Contacts
Public ContactJAM Uniken Venema
Department of Oral Kinesiology, ACTA, Room 3N-75
Outcome results
None listed