Analysis of the clinical effects of head positional therapy with the Sleep Position Trainer Wave in the treatment of Positional Obstructive Sleep Apnea

Completed

Conditions: Obstructief Slaap Apneu Syndroom
POSA (positional obstructive sleep apnea)
10046304

Registration Number: NL-OMON40474

Lead Sponsor: Sint Lucas Andreas Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

+ 18 years and older.
+ Ability to speak, read and write the local country*s language (Dutch, French or Spanish depending on the country).
+ Ability to follow up.
+ Diagnosis with symptomatic mild or moderate OSA (5 < AHI < 30).
+ Diagnosis of 10 to 90% head supine position during the night.
+ AHI head supine is 2 > as high as AHI non-supine.
+ AHI head and trunk supine is 2 > as high as AHI non-supine.
+ Own a Windows PC and ability to install SPT connection software and upload research data.
+ Expected motivation to wear the SPT Wave for 50 days.
+ Expected to maintain current lifestyle (sports, medicine, diet etc.).
+ Normal audiogram for both ears

Exclusion Criteria

- Central Sleep Apnea Syndrome.
- Night or shifting work.
- 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.
- Inability to provide informed consent.
- Simultaneous use of other treatment modalities to treat OSA.
- Hearing loss, wearing other ear devices.
- Anatomic ear abnormalities which influences correct attachment of the SPT Wave to the head and ear
- BMI above 35
- Extreme Migraine

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoints; reduction of PSG parameters, in particular AHI, AI, HI, DI,<br /><br>reduction of % of sleeping supine sleep position of the head, without<br /><br>disturbance of the sleep quality.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p> Secondary endpoints: Outcome of Quality of Life questionnaires; Epworth<br /><br>Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire (FOSQ),<br /><br>Subjective Treatment Satisfaction Questionnaire (STSQ) . Compliance and<br /><br>learning effect will also be evaluated after 50 days usage.<br /><br>Demographic parameters: Sex, age, length, weight, BMI, alcohol intake,<br /><br>medication will also be noted. </p><br>