Slaapstoornissen including nrem parasomnia sleep disorders sleep problems
Conditions
Interventions
None listed
Sponsors
Epilepsiecentrum Kempenhaeghe
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients: Participants with a suspicion of a sleep disorder, who were referred to Kempenhaeghe sleep center for a clinical PSG. Participants should be above 18 years old. Furthermore, participants must be able to read and speak Dutch.
Exclusion criteria
Exclusion criteria: Patients: Patients with an established diagnosis of epilepsy, pregnancy, participants who lack the functional capacity to provide informed consent. Participants who suffer from clinically relevant neurologic or psychiatric disorders or other somatic disorder, that influences sleep or is limiting the ability to adhere to the study procedures (for example schizophrenia or alcohol abuse), shift-workers, and use of medication influencing sleep. Patients with high clinical needs, for whom participating in the study would be a too high burden. In general, the device should not be used in the following cases: • Subjects with family history of allergic reactions to adhesives or hydrogels or have a family history of adhesive skin allergies and subjects with severe skin conditions such as wounds, burns or on any damaged skin. • Patients with external cardiac defibrillators, diaphragmatic pacers, or extra cardiac stimulators • Or in combination with high-frequency surgical equipment, near strong magnetic fields or with devices such as MRIs or cardiac stimulators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For the first primary objective, which is the development and evaluation of an algorithm for automated sleep staging, we will calculate the kappa of the agreement between the automated sleep staging based on the STS measurements and the manual sleep staging based on the gold-standard PSG. Additionally, we will determine the kappa of the agreement between automated sleep staging and manual sleep staging obtained from the Onera STS. For the second primary objective, we will assess the proportion of completed night measurements relative to the prescribed ones and the amount of time of analyzable data defined as the data that is eligible for sleep stage scoring | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes of the measurements in the sleep center are as follows: (1) evaluating the time it takes to apply the Onera STS as compared to the gold standard PSG system measured in minutes and (2) computing the difference between the number of parasomnia events, consisting of either awakenings during NREM3 sleep or body movements detected during NREM3 sleep using gold standard PSG and the Onera STS. Secondary endpoints based on the at-home measurements will include, (1) subjective perception of the Onera STS system as measured through a questionnaire, (2) the percentage of subjects who did not show any parasomnia events during in-hospital recording but did show events during the at-home recordings, and (3) the difference between the number of parasomnia events captured in the in-hospital recordings with PSG and the number of events captured with the Onera STS during at-home recordings based on the number of events when subjects get up from bed, as indicated by PADDS. | — |
Countries
Netherlands
Outcome results
None listed