NCT00170391

Brief Summary

The principal aim of the study is to evaluate if CBT for insomnia is associated with improvement in the PSG sleep of patients treated in primary care. Furthermore,the relationship between subjectively-assessed sleep and PSG sleep are investigated(at pre-treatment, at post-treatment, in relation to treatment change.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2002

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

September 15, 2005

Status Verified

October 1, 2002

First QC Date

September 10, 2005

Last Update Submit

September 10, 2005

Conditions

Insomnia

Keywords

InsomniaSleepPSGBehavioural treatment

Interventions

Quarter of an Hour ruleBEHAVIORAL

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meets clinical/RDC criteria for primary insomnia Healthy Adult (18+ years)

You may not qualify if:

  • Evidence of sleep disorders other than insomnia Use of sleeping pills Major Psychopathologies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sackler Foundation of Psychobiological Research

Glasgow, Lanarkshire, G514TF, United Kingdom

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Colin A Espie, PhD

    University of Glasgow

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 10, 2005

First Posted

September 15, 2005

Study Start

October 1, 2002

Study Completion

December 1, 2005

Last Updated

September 15, 2005

Record last verified: 2002-10

Locations

GB(1)