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van CCT (UK)

van CCT (UK)

Subtyping of Insomnia

- candidate number26667
- NTR NumberNTR6626
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-feb-2017
- Secondary IDsNL60994.015.17 METC MMC Veldhoven
- Public TitleSubtyping of Insomnia
- Scientific TitleSubtyping of Insomnia
- hypothesisChronic insomnia is a widespread problem, affecting about ten percent of the adult population. A generic and effective treatment for insomnia that targets hyperarousal is Cognitive Behavioural Therapy for insomnia (CBT-I). However, part of the insomnia patients does not respond to CBT-I and patients who do respond have variable outcomes. Scientific literature is increasingly becoming aware of the idea that insomnia is a general term for a number of subtypes consisting of different sleep complaints and having different causes. As a consequence, the effectiveness of (nonpharmacological) treatment of a patient is likely to be strongly dependent of the patientís individual characteristics. To date, no validated stratification method to subtype insomnia is available.

In this study we aim to better understand underlying mechanisms of insomnia and the heterogeneity in treatment response in a broad patient population, using cluster analysis as a tool for detecting subtypes. Subtypes will be detected with primary use of physiological parameters. Eventually, this study could lead towards finding clinically relevant subtypes, personalizing treatment and eventually even predicting if a non-pharmacological intervention for insomnia will be effective for an individual patient.
- Healt Condition(s) or Problem(s) studiedInsomnia, Insomnia
- 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- 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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-aug-2017
- planned closingdate31-jul-2020
- Target number of participants325
- InterventionsNone
- Primary outcomeThe 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 outcomeThe 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.
- TimepointsThe study will be divided into two stages with a duration of approximately 15 and 21 months respectively.
- Trial web site
- statusplanned
- CONTACT for SCIENTIFIC QUERIESdr. prof. S. Overeem
- Sponsor/Initiator Kempenhaeghe (Sleep Center)
- Funding
(Source(s) of Monetary or Material Support)
Philips Electronics Nederland B.V.
- Publications
- Brief summaryChronic insomnia is a widespread problem, affecting about ten percent of the adult population. Insomniacs form a heterogeneous group. As a consequence, a substantial part of the patients does not respond to the generic cognitive behavioral therapy (CBT-I). Large discrepancies between objective macrostructural characteristics of sleep evaluated by polysomnography and subjective reports of complaints have been found in insomnia patients. Therefore, increasing emphasis has been given to study microstructural characteristics of the EEG. Current research on EEG microstructure indicates that patients with insomnia have decreased sleep stability, possibly reflecting hyperarousal. Here, we aim to better understand underlying mechanisms of insomnia and heterogeneity in treatment response, assessing macro- and microstructural EEG parameters. Eventually, this could lead towards finding clinically relevant subtypes, personalizing treatment and even predicting individual treatment success.
Overall, 250 insomnia patients who are referred for CBT-I treatment to the Sleep Medicine Center Kempenhaeghe will take part in this study. Before the start of CBT-1, one night of ambulatory polysomnography (PSG) will be recorded at home. Cluster analysis will be used to detect groups of co-occurring macro- and microstructural EEG characteristics. We will focus on spectral power analysis, structural characteristics of REM-sleep, sleep protection mechanisms and (micro)arousals. We will evaluate these characteristics together, in order to study their relevance for phenotyping and their mutual relationships.
- Main changes (audit trail)
- RECORD9-feb-2017 - 20-aug-2017

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