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,…
ID
Bron
Verkorte titel
Aandoening
Obstructive Sleep Apnea
Mandibular Advancement Device
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
• 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>
• WristOx parameters: ODI<br>
• DISE outcomes: by using the VOTE classification with and without jaw thrust and MyTAP <br>
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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.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
• 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
Onderzoeksproduct en/of interventie
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.
Algemeen / deelnemers
JAM Uniken Venema
Gustav Mahlerlaan 3004
Amsterdam
The Netherlands
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j.a.m.unikenvenema@acta.nl
Wetenschappers
JAM Uniken Venema
Gustav Mahlerlaan 3004
Amsterdam
The Netherlands
-
j.a.m.unikenvenema@acta.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• >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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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).
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7249 |
| NTR-old | NTR7456 |
| CCMO | NL64738.100.18 |
| OMON | NL-OMON48802 |