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| [ Print-friendly version ] |
| A televised, web-based randomised trial of an herbal remedy (valerian) for insomnia |
| ISRCTN | ISRCTN72748991 |
| ClinicalTrials.gov identifier | |
| Public title | A televised, web-based randomised trial of an herbal remedy (valerian) for insomnia |
| Scientific title | |
| Acronym | SøvnStudien |
| Serial number at source | 2005001TVT |
| Study hypothesis | The primary objective is to evaluate whether valerian root (valerian) improves the self-assessed quality of sleep compared with placebo for people with primary insomnia |
| Ethics approval |
Regional Committee for Medical Research Ethics for Southern Norway (Regional komité for medisinsk forskningsetikk, Sør- Norge) 5 January 2006, Ref: S-05280
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| Study design | Randomised, double-blind, parallel group, placebo controlled trial |
| Countries of recruitment | Norway |
| Disease/condition/study domain | Primary insomnia |
| Participants - inclusion criteria |
1. Aged 18 –75 years, both inclusive
2. Insomnia lasting more than one month 3. Pittsburgh Sleep Quality Index (PSQI) score of > 5 4. Provide name of primary physician 5. Access to internet and own email address 6. At least 10 days of the sleep diary completed prior to randomisation |
| Participants - exclusion criteria |
1. Secondary insomnia
2. Use of hypnotics by prescription 3. Depression 4. Alcohol or drug abuse 5. Psychotherapy within the past six months 6. Sleep apnoea, periodic limb movements disorder or restless legs syndrome 7. Pregnant or lactating women or women of childbearing potential who do not use an approved method of contraception (oral contraceptives orIntrauterine device [IUD]) 8. Shift workers 9. History of hypersensitivity to valerian or its constituents 10. Participant rating of ‘usually’ or ‘always’ to the following questions in the Global Sleep Assessment Questionnaire: During the past four weeks, how often: a. Did you hold your breath, have breathing pauses, or stop breathing in your sleep? b. Did you have restless or "crawling" feelings in your legs at night that went away if you moved your legs? c. Did you have repeated rhythmic leg jerks or leg twitches during your sleep? d. Did you have nightmares, or did you scream, walk, punch, or kick in your sleep? e. Did any of the following disturb you in your sleep: f. Pain? g. Other physical symptoms? h. Medications? i. Did you snore loudly? 11. Current participation in another trial using an investigational compound |
| Anticipated start date | 29/01/2007 |
| Anticipated end date | 30/03/2007 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 500 to 550 |
| Interventions |
Coated Valerian Forte tablets 200 mg extract per tablet, corresponding to 1200 mg Valeriana officinalis. 3 tablets to be taken every night for 14 days
Information about the study will be televised nationally on a weekly health program. Viewers interested in participation will be invited to visit the web pages of the study to enrol. Participant registration and data collection will be by use of Internet. |
| Primary outcome measure(s) | Proportion of participants in each group with an improvement in self-assessed quality of sleep of > or = 0.5 units between the average score for the 2 weeks before and 2 weeks during treatment |
| Secondary outcome measure(s) |
1. Proportion of participants in each group with an improvement of > or = 0.5 units between the average score for the 2 weeks before and 2 weeks during treatment for each of the four variables:
1.1 Sleep latency 1.2 Number of awakenings 1.3 Total sleep time 1.4 Energy level during the day 2. Mean changes in the five outcomes listed above 3. Global self-assessment If a difference is not found between the treatment groups for the primary and secondary variables, the following explorative variables will be analysed: 1. Proportion of participants in each group with any improvement in mean difference (i.e. all score changes > 0) between the average score for the 2 weeks before and 2 weeks during treatment for each of the five variables: 1.1 Quality of sleep 1.2 Sleep latency 1.3 Number of awakenings 1.4 Total sleep time 1.5 Energy level during the day 2. Difference in the profile of the five endpoints during the intervention period taking into account the baseline period, including a potential time effect |
| Sources of funding |
Norwegian Knowledge Centre for the Health Services (Norway)
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| Trial website | http://sovnstudien.forskningspuls.no/ |
| Publications | Results on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17940604 |
| Contact name | Dr Andrew David Oxman |
| Address |
Norwegian Knowledge Centre for the Health Services
P.O. Box 7004 St. Olavs plass |
| City/town | Oslo |
| Zip/Postcode | N-0130 |
| Country | Norway |
| oxman@online.no | |
| Sponsor | Norwegian Knowledge Centre for the Health Services (Norway) |
| Address |
P.O. Box 7004
St. Olavs plass |
| City/town | Oslo |
| Zip/Postcode | N-0130 |
| Country | Norway |
| post@kunnskapssenteret.no | |
| Sponsor website: | http://www.kunnskapssenteret.no |
| Date applied | 22/01/2007 |
| Last edited | 25/10/2007 |
| Date ISRCTN assigned | 01/03/2007 |
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