No registrations found.
ID
Source
Brief title
Health condition
Obstructive Sleep Apnea
Mandibular Advancement Device
Sponsors and support
Intervention
Outcome measures
Primary outcome
• 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 outcome
• 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
Background summary
This study evaluates whether the boil and bite MAD, MyTAP, can be used as a screening tool to predict treatment success with MAD therapy. Besides the boil and bite MyTAP will be compared to a custom MAD, named TAP1, on short-term outcomes. The aim of the study is to evaluate DISE outcomes, PSG parameters, WristOx parameters, patient’s compliance, satisfaction and improvement in quality of life of a boil and bite MAD and a custom MAD during a follow-up period of 12 weeks.
Study objective
This study evaluates whether the boil and bite Mandibular Advancement Device (MAD), MyTAP, can be used as a screening tool to predict treatment success with MAD therapy. Besides the boil and bite MyTAP will be compared to a custom MAD, named TAP1, on short-term outcomes. The aim of the study is to evaluate Drug Induced Sleep Endoscopy (DISE) outcomes, Polysomnographic parameters, WristOx parameters, patient’s compliance, satisfaction and improvement in quality of life of a boil and bite MAD and a custom MAD during a follow-up period of 12 weeks.
Study design
• DISE outcomes: at baseline
• PSG parameters: at baseline, after 12 weeks follow-up MyTAP, after 12 weeks follow-up TAP1
• WristOx parameters: at baseline, after 12 weeks follow-up MyTAP, after 12 weeks follow-up TAP1
• Questionnaires: at baseline, after 12 weeks follow-up MyTAP, after 12 weeks follow-up TAP1
• Mandibular advancement: after 12 weeks follow-up MyTAP, after 12 weeks follow-up TAP1
• Compliance and treatment satisfaction: after 12 weeks follow-up MyTAP, after 12 weeks follow-up TAP1
• Adverse Events: after 12 weeks follow-up MyTAP, after 12 weeks follow-up TAP1, if necessary
Intervention
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 period of 1 week. After each period of 12 weeks a comprehensive sleep study and questionnaire survey are performed.
JAM Uniken Venema
Gustav Mahlerlaan 3004
Amsterdam
The Netherlands
-
j.a.m.unikenvenema@acta.nl
JAM Uniken Venema
Gustav Mahlerlaan 3004
Amsterdam
The Netherlands
-
j.a.m.unikenvenema@acta.nl
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
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
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7249 |
| NTR-old | NTR7456 |
| CCMO | NL64738.100.18 |
| OMON | NL-OMON48802 |