Positional therapy with the Sleep Position Trainer versus oral appliance therapy with the MRA in patients with position dependent Obstructive Sleep Apnea; A Randomised Controlled Trial
- Conditions
- sleepingdisorder with apnoeas10046304
- Registration Number
- NL-OMON40088
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 90
+ Diagnosis with symptomatic mild or moderate OSA (5 < AHI < 30).
+ Diagnosis of 10 to 90% supine position during the night.
+ AHI supine is >2 times as high as AHI non-supine.
- Many dental problems; insufficient teeth for wearing MRA.
- Medication used/ related to sleeping disorders
- Central Sleep Apnoea Syndrome.
- Night or shifting work.
- Severe chronic heart failure.
- Medical history of known causes of tiredness by day or severe sleep disruption (insomnia, PLMS, Narcolepsy).
- Seizure disorder.
- Known medical history of mental retardation, memory disorders or psychiatric disorders.
- Patients with old type of pacemakers (It is possible that old types of peacemakers are not
compatible with the electromagnetic radiation of the electronics of the SPT).
- Shoulder, neck and back complaints
- Reversible morphological upper airway abnormalities (e.g. enlarged tonsils).
- Inability to provide informed consent.
- Simultaneous use of other treatment modalities to treat OSA.
- Previous treatment for OSA
- Pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main study parameters/ endpoints: Primary endpoints; reduction of PSG<br /><br>parameters, in particular AHI, AI, HI, DI, reduction of % of sleeping supine<br /><br>sleep position, without disturbance of the sleep quality. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints: Outcome of Quality of Life questionnaires; ESS, FOSQ,<br /><br>OHIP-14 and MFIQ. Compliance and learning effect will also be evaluated in 3<br /><br>and 12 months. Finally the cardiovascular parameters like blood pressure, pulse<br /><br>rate and BMI/neck circumference will be assessed.</p><br>