Explorative study on unobtrusive sleep monitoring technologies: prolonged in-home measuring in the sleep-disordered population (PRISM study)

Completed

Conditions: apnea
Insomnia
periodic limb movement disorder
10040991

Registration Number: NL-OMON51152

Lead Sponsor: Technische Universiteit Eindhoven

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 125

Inclusion Criteria

- Patients with the suspicion of sleep disorders which are referred to
Kempenhaeghe Center of Sleep Medicine for a clinical evaluation.
- Planned for a clinical polysomnography at Kempenhaeghe
- 18 years or above
- Wi-Fi at home that can be used

Exclusion Criteria

- Suspicion of too complex comorbid sleep disorders (assessed by the clinical
sleep expert)
- Suspicion of underlying severe neurological or psychiatric disorders
- Known allergies for hard plastic or elastic band material
- Presence of wounds, injuries, or inflammation on the skin where the wristband
or headband will be placed

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Macrostructural sleep parameters:<br /><br>- Hypnogram<br /><br>- Sleep stages: Wake, N1, N2, N3, REM<br /><br>- Total Sleep Time (TST)<br /><br>- Sleep Onset Latency (SOL)<br /><br>- Wake After Sleep Onset (WASO)<br /><br>- Sleep Efficiency (SE)<br /><br>- Time In Bed (TIB)<br /><br>- Sleep stage transitions<br /><br>Heart rate (variability)<br /><br>Respiratory activity<br /><br>Apnea-hypopnea index (AHI, events per hour)<br /><br>Oxygen saturation<br /><br>Brain activity parameters: Delta (<4 Hz), Theta (4-8 Hz), Alpha (8-12 Hz), Beta<br /><br>(12-30 Hz), and Gamma (>30 Hz) activity<br /><br>Night-to-night variability in parameters</p><br>

Secondary Outcome Measures