| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN38174888 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0038183440 |
| Public title | Serotonin sensitivity in insomnia: a placebo-controlled crossover study of sleep after 5HT2 blockade in primary insomnia |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Nervous System Diseases: Carpal tunnel decompression |
| Study hypothesis | Does Trazodone improve sleep in primary insomnia? |
| Design/methodology | Placebo-controlled crossover study |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Adults referred to Psychopharmacology Unit Clinic 7, Bristol Royal Infirmary with psycho-physiological insomnia
2. Complaint of poor sleep with daytime consequences |
| Participants - exclusion criteria | 1. Taking psychotropic medication
2. Total sleep time (subjective) > 6.5 hours
3. Current psychiatric disorder |
| Patient information material |
|
| Anticipated start date | 28/04/2006 |
| Anticipated end date | 31/01/2008 |
| Status of trial | Completed |
| Target number of participants | 12 insomnia patients |
| Interventions | RCT: [A] trazodone; [B] placebo.
Randomised, double-blind, placebo-controlled crossover study.
Overnight sleep patterns recorded and compared, after either placebo or trazodone 100mg. Each patient has screening visit and 2 overnight sleep recordings at home a week apart, plus an end-of study visit. |
| Primary outcome measure(s) | Sleep efficiency: % Total Sleep Time / Staging Time. |
| Secondary outcome measure(s) | 1. Daily symptom report (DSR)
2. Total sleep time (TST)
3. Number of awakenings
4. Wake Time After Sleep Onset (WASO)
5. Time spent in stages 1 to 4 and rapid eye movement (REM), %TST spent in each stage
6. REM onset latency
7. Sleep onset Latency (SOL), slow wave activity
8. Leeds Sleep Evaluation Questionnaire. |
| Sources of funding | Avon and Wiltshire Mental Health Partnership NHS Trust
AWP Partnership Mental Health NHS Trust R&D Project grant
NHS R&D Support Funding |
| Sponsor name | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Dr Wilson Sue |
| Contact details | University of Bristol
Dorothy Hodgkin Building
Whitson Street
Bristol
United Kingdom
BS1 3NY |
| Contact telephone | +44 0117 331 3172 |
| Contact fax | +44 0117 331 3180 |
| Contact email | sue.wilson@bris.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN38174888 |
| Date last extracted from ISRCTN register | 17/04/2008 |
