InsomniaNCT00170391
Do People With Insomnia Sleep Better After Psychological Treatment?
A study testing Quarter of an Hour rule in people with Insomnia, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia
- What is being tested?
- Quarter of an Hour rule
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2002to Dec 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Meets clinical/RDC criteria for primary insomnia Healthy Adult (18+ years)
Who cannot join
- Evidence of sleep disorders other than insomnia Use of sleeping pills Major Psychopathologies
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sackler Foundation of Psychobiological Research
Glasgow, Lanarkshire, G514TF
About this study
Official title: Does CBT for Insomnia Improve the PSG Sleep of Patients Treated in Primary Care?
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.
- Conditions
- Insomnia
- Being tested
- Quarter of an Hour rule
- Keywords
- Insomnia, Sleep, PSG, Behavioural treatment
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quarter of an Hour ruleBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startOct 2002
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Investigators
- Colin A Espie, PhD, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00170391
- Sponsor's protocol ID
- 02CP08
- Other IDs
- 32966/1
- Status last verified
- Oct 2002
- First submitted
- 10 Sep 2005
- Last updated
- 15 Sep 2005
- Results posted
- No
Publications
Espie CA, Tse KYK, Malaffo M. Efficacy of the 'Quarter-of-an-Hour-Rule' Single Instruction Derived from Stimulus Control Therapy for Insomnia: A Pragmatic Open-Label, Randomized Controlled Trial. Behav Sleep Med. 2026 Aug 30:1-19. doi: 10.1080/15402002.2026.2724278. Online ahead of print.
PubMed 42669058
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does CBT for Insomnia Improve the PSG Sleep of Patients Treated in Primary Care?
- ClinicalTrials.gov ID
- NCT00170391
- Acronym / sponsor ID
- 02CP08
- Conditions
- Insomnia
- Keywords
- Insomnia, Sleep, PSG, Behavioural treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Study start
- Oct 2002
- Study completion
- Dec 2005
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Meets clinical/RDC criteria for primary insomnia Healthy Adult (18+ years)
Key exclusion criteria (1 listed)
- Evidence of sleep disorders other than insomnia Use of sleeping pills Major Psychopathologies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quarter of an Hour rule | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2005.
- Derived from this study: PubMed 42669058Espie CA, Tse KYK, Malaffo M. Efficacy of the 'Quarter-of-an-Hour-Rule' Single Instruction Derived from Stimulus Control Therapy for Insomnia: A Pragmatic Open-Label, Randomized Controlled Trial. Behav Sleep Med. 2026 Aug 30:1-19. doi: 10.1080/15402002.2026.2724278. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colin A Espie, PhD principal investigator
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quarter of an Hour rule in people with Insomnia, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00170391, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2005.