A televised, web-based randomised trial of an herbal remedy (valerian) for insomnia
| ISRCTN | ISRCTN72748991 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72748991 |
| Secondary identifying numbers | 2005001TVT |
- Submission date
- 22/01/2007
- Registration date
- 01/03/2007
- Last edited
- 25/10/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Andrew David Oxman
Scientific
Scientific
Norwegian Knowledge Centre for the Health Services
P.O. Box 7004
St. Olavs plass
Oslo
N-0130
Norway
| oxman@online.no |
Study information
| Study design | Randomised, double-blind, parallel group, placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | SøvnStudien |
| 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(s) | Regional Committee for Medical Research Ethics for Southern Norway (Regional komité for medisinsk forskningsetikk, Sør- Norge) 5 January 2006, Ref: S-05280 |
| Condition | Primary insomnia |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | 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 measures | 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 |
| Overall study start date | 29/01/2007 |
| Overall study end date | 30/03/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 500 to 550 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 29/01/2007 |
| Recruitment end date | 30/03/2007 |
Locations
Countries of recruitment
- Norway
Study participating centre
Norwegian Knowledge Centre for the Health Services
Oslo
N-0130
Norway
N-0130
Norway
Sponsor information
Norwegian Knowledge Centre for the Health Services (Norway)
Government
Government
P.O. Box 7004
St. Olavs plass
Oslo
N-0130
Norway
| post@kunnskapssenteret.no | |
| Website | http://www.kunnskapssenteret.no |
"ROR" |
https://ror.org/01thff661 |
Funders
Funder type
Government
Norwegian Knowledge Centre for the Health Services (Norway)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 17/10/2007 | Yes | No |
