A televised, web-based randomised trial of an herbal remedy (valerian) for insomnia

ISRCTN	ISRCTN72748991
DOI	https://doi.org/10.1186/ISRCTN72748991
Protocol serial number	2005001TVT
Sponsor	Norwegian Knowledge Centre for the Health Services (Norway)
Funder	Norwegian Knowledge Centre for the Health Services (Norway)

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 of protocol

Not provided at time of registration

Contact information

Dr Andrew David Oxman
Scientific

Norwegian Knowledge Centre for the Health Services
P.O. Box 7004
St. Olavs plass
Oslo
N-0130
Norway

Email	oxman@online.no

Study information

Primary study design	Interventional
Study design	Randomised, double-blind, parallel group, placebo controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	SøvnStudien
Study objectives	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
Health condition(s) or problem(s) studied	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(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
Key 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
Completion date	30/03/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	550
Key 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
Key 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
Date of first enrolment	29/01/2007
Date of final enrolment	30/03/2007

Locations

Countries of recruitment

Norway

Study participating centre

Norwegian Knowledge Centre for the Health Services

Oslo
N-0130
Norway

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Study website	Study website	11/11/2025	11/11/2025	No	Yes