A comparison between two different oral appliance therapies: Somnodent vs Herbst appliance in patients with mild and moderate OSA; a Randomised Controlled Trial

Completed

Conditions: Obstructive Sleep Apnea
10046304

Registration Number: NL-OMON45035

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 140

Inclusion Criteria

+ 18 years and older
+ Ability to speak, read, and write Dutch.
+ Ability to follow-up.
+ Ability to use a computer with internet connection for online questionnaires.
+ Diagnosis with symptomatic mild or moderate OSA (5 < AHI < 30).
+ Expected to maintain current lifestyle (sports, medicine, diet, etc.)

Exclusion Criteria

- Untreated periodontal problems, dental pain, and a lack of retention possibilities for an MAD.
- Medication used/related to sleeping disorders.
- Evidence of respiratory/sleep disorders other than OSA (eg. central sleep apnea syndrome).
- Systemic disorders (based on medical history and examination; e.g. rheumatoid arthritis)
- Temporomandibular disorders (based on the function examination of the masticatory system).
- Medical history of known causes of tiredness by day, or severe sleep disruption (insomnia, PLMS, Narcolepsy).
- Known medical history of mental retardation, memory disorders, or psychiatric disorders.
- Reversible morphological upper airway abnormalities (e.g. enlarged tonsils).
- Inability to provide informed consent.
- simultaneous use of other modalities to treat OSA.
- Previous treatment with a MAD.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoints: reduction of PSG parameters, in particular Apnoea Hypopnoea<br /><br>Index (AHI), Apnoea Index (AI), Hypopnoea Index (HI), Desaturation Index (DI),<br /><br>and sleep efficiency at baseline, 3 months, and 1 year.<br /><br><br /><br>Addendum CBCT:<br /><br><br /><br>Primary endpoint: minimum cross-sectional area (CSAmin); mandibular length<br /><br>(me-go).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints: outcome of Quality of Life (QoL) questionnaires; the QoL<br /><br>is measured with questionnaires regarding general health (EQUOL), sleep health<br /><br>and daily functioning (AMCSQ, ESS, FOSQ), and functionality of the dentition<br /><br>and jaws (RDC/TMD and MFIQ) at baseline, 3, 6, 9 and 12 months. Compliance will<br /><br>also be evaluated for the time period of 3, 6, 9 and 12 months<br /><br><br /><br>Addendum CBCT:<br /><br>Secondary endpoints are upper airway size: anterior-posterior (AP) and lateral<br /><br>(L) dimensions of the CSAmin, and the volume of the upper airway (V); upper<br /><br>airway shape: 2-D shape of the upper airway (AP/L); and 3-D shape of the upper<br /><br>airway (CSAmin / CSAavg); face width (tl-tr), anterior neck space area<br /><br>(ste-cr-ty-cer-me), and cervicomental angle (np-cer-me).</p><br>