search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Alle Klokken Gelijk


- candidate number14921
- NTR NumberNTR4010
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-mei-2013
- Secondary IDs12/472 METc VUmc
- Public TitleAlle Klokken Gelijk
- Scientific TitleOnTime: an integrated approach to sleep improvement
- ACRONYMOnTime insomnia
- hypothesisInsomnia patients form a heterogeneous group, each phenotypes of insomnia will show different therapeutic demands.
- Healt Condition(s) or Problem(s) studiedInsomnia, Phenotype
- Inclusion criteria1) 18-70 years of age;
2) Insomnia.
- Exclusion criteria1) Other neurological or psychiatric disorders eye diseases;
2) Cardiovascular or movement disorders;
3) Shiftworkers;
4) Use of sleep medication 3 months prior to inclusion;
5) Habitual level of light intake, physical activity or bathing habits equal to therapy.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupFactorial
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2013
- planned closingdate1-jun-2016
- Target number of participants480
- InterventionsWeb-based cognitive behavioral therapy for insomnia (CBT-I)
3 forms of chronobiological therapy (CT):
-Bright light therapy
-Thermoregulatory therapy
-Physical activity
Combinations of CBT-I and CTs.
- Primary outcomeThe change from baseline to post-treatment on a composite score that summarizes subjectie insomnia complaints, queried daily through an internet diary.
- Secondary outcomeActigrapphically estimated objective sleep parameters.
- TimepointsBaseline, 5 weeks and 10 weeks.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES Kim Dekker
- CONTACT for SCIENTIFIC QUERIESDr. E.J.W. Someren, van
- Sponsor/Initiator Netherlands Institute for Brain Research
- Funding
(Source(s) of Monetary or Material Support)
STW/NWO
- PublicationsN/A
- Brief summaryInsomnia is a condition that affects about 10% of the Western population. At present, the most common solution provided by primary care givers is pharmacological treatment. However, pharmacological treatments have a high prevalence of negative side effects. Two more recently developed treatments are chronobiological treatment (CT) and cognitive behavioral therapy (CBT). They appear safer and have more sustained effects. A problem facing implementation of CBT-I is that there are hardly any skilled therapists. Web-based CBT-I may this alleviate this problem. A second opportunity for optimization of treatment is based on the contention that the people with insomnia most likely represent a heterogeneous mix of different subtypes, with different underlying causes and expected treatment response. This is the first step in the development of a protocol for individualized optimal treatment for specific phenotypes of insomnia, where each phenotype may show different CT and CBT-I demands.
In a systematic way the effectiveness of CT, CBT-I and their combination will be evaluated for the different phenotypes.
- Main changes (audit trail)
- RECORD27-mei-2013 - 4-jun-2013


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl