Sleep Initiation and Maintenance DisordersPhase 2NCT00097604
Effects of Valerian on Sleep in Healthy Older Adults
A Phase 2 study testing Valerian root extract in people with Sleep Initiation and Maintenance Disorders, run by University of Washington at 1 site in United States.
Trial summary
The purpose of this study is to examine the way valerian, an herbal sleep agent, is absorbed and distributed in the body. This study will also compare the effects of valerian after 1 week versus after 2 weeks. Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders
- What is being tested?
- Valerian root extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Apr 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pittsburgh Sleep Quality Instrument score higher than 5
- Insomnia Severity Index score less than 22
- At least 5 years past menopause, for female participants
Who cannot join
- Current use of prescribed or over-the-counter sleep medications
- Plans to move from the area within 2 months of study entry
- Significant signs and symptoms of sleep apnea; periodic leg movements in sleep (PLMS) associated with arousals; rapid eye movement (REM) behavior disorder; restless legs syndrome; advanced sleep phase syndrome; delayed sleep phase syndrome; or any other sleep disorder, including severe insomnia or a history of chronic insomnia, for which standard therapy would be the treatment of choice
- Shift work within 6 months prior to study entry
- Current unusual or highly unstable sleep schedule
- Trans-meridian travel across more than three time zones within 4 weeks prior to study entry
Show all 13Show fewer
- Body mass index between 18 kg/m2 and 32 kg/m2
- Significant and uncontrolled major illness or psychiatric disease
- Cognitive impairment
- Current life stress
- Use of tobacco within 6 months prior to study entry
- Excessive use of alcohol or caffeine
- Currently taking hormone replacement therapy hypnotic or psychotropic medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Valerian for Sleep Disturbance in Healthy Older Adults
The purpose of this study is to examine the way valerian, an herbal sleep agent, is absorbed and distributed in the body. This study will also compare the effects of valerian after 1 week versus after 2 weeks.
Read the detailed description
Sleep disturbances are common among the elderly and may increase the risk for depression and early mortality. Use of over-the-counter sleep aids may disrupt sleep patterns and have serious side effects. Herbal medicines have the potential to improve sleep quality. Evidence suggests that valerian may improve sleep with a low rate of side effects, but its efficacy has not been thoroughly examined in the elderly. This study will determine the effectiveness and pharmacokinetics (PK) of valerian in older adults who experience disturbances in their sleep.
This study will last 8 weeks. At the sleep clinic, participants will be randomly assigned to receive either valerian or placebo on the first night of study enrollment. Participants will have an intravenous (IV) line inserted into their arms and multiple blood draws will be taken during their sleep for PK studies. The next day, participants will be sent home for a drug wash-out period and will return after 1 week for a 3-night stay at the clinic on Nights 8, 9, and 10. On Night 8, participants will adjust to their surroundings and begin a sleep log to describe the quality of their sleep; they will continue to note observations on their sleep in the sleep log for the duration of the study. Recordings of each participant's sleeping and breathing patterns will be taken on Nights 8 and 9 to screen for sleep disorders. On Night 10, participants will again be randomly assigned to receive either valerian or placebo. After Night 10, participants will be sent home and asked to continue taking their assigned intervention nightly for 11 nights. Participants will be asked to continue their sleep logs and begin a symptom log describing insomnia symptoms. After 11 nights, participants will return for another 3-night stay at the clinic on Nights 22, 23, and 24; participants will receive either valerian or placebo. Participants will then be sent home for a 12-day drug wash-out period; participants will return to the clinic for Nights 37 and 38. Night 37 will be an adaptation night; on Night 38, participants will be given the intervention they were not yet assigned on Night 24. After Night 38, participants will be asked to go home and continue their second treatment for 11 nights; participants will come back to the sleep clinic for another 3-night stay on Nights 50, 51, and 52 for observation and PK studies. After Night 52, participants will be sent home and asked to continue their sleep and symptoms logs for two more nights, then mail the logs to study researchers for analysis.
During this study, participants will be asked to keep logs of the quality of their sleep and of the insomnia symptoms they may be experiencing. In addition to the logs, post-sleep interviews will be used to assess the quality of participants' sleep and the number of awakenings. Participants' heart and breathing rates and leg movements will be measured during their stays at the sleep clinic. Participants will also have an activity monitoring device attached to either their wrist or waist for most of the study.
- Being tested
- Valerian root extract
- Keywords
- Sleep, Aged, Valerian, Complementary Therapies, Medicine, Herbal
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valerian root extractDietary supplement
Also called Valerian
Valerian root extract, 100 mg softgels, 3 softgels each night for 2 weeks, 30 minutes before bedtime
| Study group | Role | What they receive |
|---|---|---|
| Valerian | Experimental | This study used a cross-over design with valerian compared to placebo. Group 1 received valerian first followed by placebo after washout and cross-over; group 2 received placebo first followed by placebo after wash-out and cross-over. Receives: Dietary Supplement: Valerian root extract |
| Placebo | Placebo comparator | This study used a cross-over design with valerian compared to placebo. Group 1 received valerian first followed by placebo after washout and cross-over; group 2 received placebo first followed by placebo after wash-out and cross-over. Receives: Dietary Supplement: Valerian root extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep quality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2004 (estimated)
- Study startSep 2004
- Primary completionApr 2006
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Initiation and Maintenance DisordersStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Investigators
- Carol A. Landis, DNSc, Principal investigator, University of Washington, School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00097604
- Sponsor's protocol ID
- 26241-D
- Other IDs
- R21AT002108-01, 04-2201-D 01
- Status last verified
- Dec 2009
- First submitted
- 24 Nov 2004
- Last updated
- 29 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Taibi DM, Vitiello MV, Barsness S, Elmer GW, Anderson GD, Landis CA. A randomized clinical trial of valerian fails to improve self-reported, polysomnographic, and actigraphic sleep in older women with insomnia. Sleep Med. 2009 Mar;10(3):319-28. doi: 10.1016/j.sleep.2008.02.001. Epub 2008 May 14.
PubMed 18482867
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Valerian for Sleep Disturbance in Healthy Older Adults
- ClinicalTrials.gov ID
- NCT00097604
- Acronym / sponsor ID
- 26241-D
- Keywords
- Sleep, Aged, Valerian, Complementary Therapies, Medicine, Herbal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Sep 2004
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 25 Nov 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the way valerian, an herbal sleep agent, is absorbed and distributed in the body. This study will also compare the effects of valerian after 1 week versus after 2 weeks.
Detailed description
Sleep disturbances are common among the elderly and may increase the risk for depression and early mortality. Use of over-the-counter sleep aids may disrupt sleep patterns and have serious side effects. Herbal medicines have the potential to improve sleep quality. Evidence suggests that valerian may improve sleep with a low rate of side effects, but its efficacy has not been thoroughly examined in the elderly. This study will determine the effectiveness and pharmacokinetics (PK) of valerian in older adults who experience disturbances in their sleep.
This study will last 8 weeks. At the sleep clinic, participants will be randomly assigned to receive either valerian or placebo on the first night of study enrollment. Participants will have an intravenous (IV) line inserted into their arms and multiple blood draws will be taken during their sleep for PK studies. The next day, participants will be sent home for a drug wash-out period and will return after 1 week for a 3-night stay at the clinic on Nights 8, 9, and 10. On Night 8, participants will adjust to their surroundings and begin a sleep log to describe the quality of their sleep; they will continue to note observations on their sleep in the sleep log for the duration of the study. Recordings of each participant's sleeping and breathing patterns will be taken on Nights 8 and 9 to screen for sleep disorders. On Night 10, participants will again be randomly assigned to receive either valerian or placebo. After Night 10, participants will be sent home and asked to continue taking their assigned intervention nightly for 11 nights. Participants will be asked to continue their sleep logs and begin a symptom log describing insomnia symptoms. After 11 nights, participants will return for another 3-night stay at the clinic on Nights 22, 23, and 24; participants will receive either valerian or placebo. Participants will then be sent home for a 12-day drug wash-out period; participants will return to the clinic for Nights 37 and 38. Night 37 will be an adaptation night; on Night 38, participants will be given the intervention they were not yet assigned on Night 24. After Night 38, participants will be asked to go home and continue their second treatment for 11 nights; participants will come back to the sleep clinic for another 3-night stay on Nights 50, 51, and 52 for observation and PK studies. After Night 52, participants will be sent home and asked to continue their sleep and symptoms logs for two more nights, then mail the logs to study researchers for analysis.
During this study, participants will be asked to keep logs of the quality of their sleep and of the insomnia symptoms they may be experiencing. In addition to the logs, post-sleep interviews will be used to assess the quality of participants' sleep and the number of awakenings. Participants' heart and breathing rates and leg movements will be measured during their stays at the sleep clinic. Participants will also have an activity monitoring device attached to either their wrist or waist for most of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Valerian | Experimental | Dietary Supplement: Valerian root extractThis study used a cross-over design with valerian compared to placebo. Group 1 received valerian first followed by placebo after washout and cross-over; group 2 received placebo first followed by placebo after wash-out and cross-over. |
| Placebo | Placebo comparator | Dietary Supplement: Valerian root extractThis study used a cross-over design with valerian compared to placebo. Group 1 received valerian first followed by placebo after washout and cross-over; group 2 received placebo first followed by placebo after wash-out and cross-over. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pittsburgh Sleep Quality Instrument score higher than 5
- Insomnia Severity Index score less than 22
- At least 5 years past menopause, for female participants
Key exclusion criteria (13 listed)
- Current use of prescribed or over-the-counter sleep medications
- Plans to move from the area within 2 months of study entry
- Significant signs and symptoms of sleep apnea; periodic leg movements in sleep (PLMS) associated with arousals; rapid eye movement (REM) behavior disorder; restless legs syndrome; advanced sleep phase syndrome; delayed sleep phase syndrome; or any other sleep disorder, including severe insomnia or a history of chronic insomnia, for which standard therapy would be the treatment of choice
- Shift work within 6 months prior to study entry
- Current unusual or highly unstable sleep schedule
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Valerian root extractAlso: ValerianValerian root extract, 100 mg softgels, 3 softgels each night for 2 weeks, 30 minutes before bedtime | Dietary supplement | Placebo, Valerian |
Primary outcome
Sleep quality
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2010.
- Results publication: PubMed 18482867Taibi DM, Vitiello MV, Barsness S, Elmer GW, Anderson GD, Landis CA. A randomized clinical trial of valerian fails to improve self-reported, polysomnographic, and actigraphic sleep in older women with insomnia. Sleep Med. 2009 Mar;10(3):319-28. doi: 10.1016/j.sleep.2008.02.001. Epub 2008 May 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carol A. Landis, DNSc principal investigator
University of Washington, School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Valerian root extract in people with Sleep Initiation and Maintenance Disorders, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep quality. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00097604, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2010.