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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40474

Enrollment

Registered

2014-02-03

Start date

2014-03-01

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructief Slaap Apneu Syndroom POSA (positional obstructive sleep apnea)

Interventions

A new product for head positional therapy, the SPT Wave, has been developed based on the same working principle of the Sleep Position Trainer but now focusing specifically on head positional therapy

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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 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

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

Design outcomes

Primary

Measure	Time frame
Primary endpoints; reduction of PSG parameters, in particular AHI, AI, HI, DI, reduction of % of sleeping supine sleep position of the head, without disturbance of the sleep quality.	—

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)