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Subtyping of Insomnia

Subtyping of Insomnia

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON28159
Enrollment
325
Registered
2017-02-09
Start date
2017-08-01
Completion date
Unknown
Last updated
2024-06-11

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

Conditions

Insomnia, insomnie, slapeloosheid

Interventions

None

Sponsors

Sleep Center Kempenhaeghe
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Referred to sleep center Kempenhaeghe for CBT-I - Age older than 18 - Subjective problems with falling asleep, maintaining sleep or early awakening - A duration of insomnia of more than three months - The sleep disturbance causes clinically significant distress or impairment - Patients who live at a driving distance of less than approximately 70 km from Kempenhaeghe. This includes the regions Limburg-Noord, Brabant-Noord, Brabant-Zuidoost, Midden-Brabant and Gelderland-Zuid.

Exclusion criteria

Exclusion criteria: - Patients with conditions which will prevent taking part in neuropsychological tests, for example due to language deficiency - Pregnancy - Insomnia that occurs exclusively during the course of a mental disorder or due to medication or drug abuse - Patients who lack the functional capacity to provide informed consent - Patients who are not able to adhere to the study protocol due to severe neurologic or psychiatric disorders, for example schizophrenia or alcohol abuse

Design outcomes

Primary

MeasureTime frame
The primary endpoints of the study are the different subtypes of insomnia and their relevant characteristics. We will mainly look at macro and microstructural characteristics of the EEG (measured by at home polysomnography during one night), as well as heart rate variability.

Secondary

MeasureTime frame
The secondary endpoints of the study are the characteristics of the subtypes, changes of ECG, finger PPG and microstructural EEG parameters observed after CBT-I treatment and validity and reliability of HF measured by wrist-worn PPG.

Contacts

Public ContactS. Overeem
OvereemS@kempenhaeghe.nl+31-(0)40-227 92 35

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)