Condition category
Signs and Symptoms
Date applied
22/01/2007
Date assigned
01/03/2007
Last edited
25/10/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://sovnstudien.forskningspuls.no/

Contact information

Type

Scientific

Primary contact

Dr Andrew David Oxman

ORCID ID

Contact details

Norwegian Knowledge Centre for the Health Services
P.O. Box 7004
St. Olavs plass
Oslo
N-0130
Norway
oxman@online.no

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2005001TVT

Study information

Scientific title

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

Regional Committee for Medical Research Ethics for Southern Norway (Regional komité for medisinsk forskningsetikk, Sør- Norge) 5 January 2006, Ref: S-05280

Study design

Randomised, double-blind, parallel group, placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

29/01/2007

Overall trial end date

30/03/2007

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

500 to 550

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

Trial participating centre

Norwegian Knowledge Centre for the Health Services
Oslo
N-0130
Norway

Sponsor information

Organisation

Norwegian Knowledge Centre for the Health Services (Norway)

Sponsor details

P.O. Box 7004
St. Olavs plass
Oslo
N-0130
Norway
post@kunnskapssenteret.no

Sponsor type

Government

Website

http://www.kunnskapssenteret.no

Funders

Funder type

Government

Funder name

Norwegian Knowledge Centre for the Health Services (Norway)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17940604

Publication citations

  1. Results

    Oxman AD, Flottorp S, Håvelsrud K, Fretheim A, Odgaard-Jensen J, Austvoll-Dahlgren A, Carling C, Pallesen S, Bjorvatn B, A televised, web-based randomised trial of an herbal remedy (valerian) for insomnia., PLoS ONE, 2007, 2, 10, e1040, doi: 10.1371/journal.pone.0001040.

Additional files

Editorial Notes