InsomniaPhase 2NCT00303342
Neuroendocrine Mechanisms in Behavioral Treatment of Insomnia
A Phase 2 study testing mind body treatment and desensitization in people with Insomnia, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the change in measures of physiological arousal before and after behavioral treatment of insomnia. Read more about this study
- Who is it for?
- Ages 21 to 59 years
- Conditions the study is for
- Insomnia
- What is being tested?
- mind body treatment and desensitization
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Jun 2009
- 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 21 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- primary insomnia for 6 months
- average total wake time >60 minutes and sleep efficiency <80%
- at least 1 daytime complaint due to insomnia
- adequate opportunity and circumstance for sleep
Who cannot join
- current psychiatric condition
- medical condition that interferes with sleep
- pregnancy
- rotating shift work, night work or transcontinental travel during study
- anticipated major life stressor over the course of the study
- use of hypnotic or psychoactive medications
- no idiopathic or sleep state misperception insomnia
Trial locations and contacts
1 site in 1 country.
United States1 site
Sleep Disorders Program, Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
The purpose of this study is to evaluate the change in measures of physiological arousal before and after behavioral treatment of insomnia.
Read the detailed description
There is good evidence that physiological arousal, associated with sustained activation of the hypothalamic-pituitary axis and the sympathetic nervous system, is an underlying cause of chronic insomnia. Accordingly, relaxation-related treatments that address elevated cognitive and somatic arousal have been effective for insomnia. Previous studies have documented the effectiveness of behavioral treatments in reducing activation of the hypothalamic-pituitary axis and the sympathetic nervous system and in the treatment of specific medical disorders including insomnia. The aim of this proposal is to evaluate the hypothesis that improvements in chronic psychophysiological insomnia following a behavioral treatment are tightly associated with reduction of arousal in the hypothalamic-pituitary axis, as measured by plasma cortisol, and in the sympathetic nervous system, as measured by urinary catecholamines. Objective measures of sleep will be derived from polysomnographic recordings from subjects randomized into a 10-week active behavioral treatment or placebo behavioral control treatment group. Continuous 24-hour evaluation of cortisol and catecholamines will be performed under controlled laboratory conditions before and after treatment. We anticipate significant reductions in cortisol and catecholamines in the active treatment group as compared with the control group. We also anticipate that the active treatment will yield reductions in related measures of arousal including heart rate, autonomic arousal (as determined from heart rate variability), and body temperature. Given reported evidence that melatonin levels are chronically low in insomnia we anticipate an increase in the sleep-related hormone melatonin in the yoga treatment group. If achieved, these results will provide a novel demonstration of a reduction of arousal in a behavioral insomnia treatment and a behaviorally enhanced melatonin secretion under controlled laboratory conditions.
- Conditions
- Insomnia
- Being tested
- mind body treatment, desensitization
- Keywords
- sleep, arousal, stress, cortisol, catecholamines
- 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.
mind body treatmentBehavioural
regulation of attention, respiration and posture
desensitizationBehavioural
mentation on insomnia behaviors and cognitive activity
| Study group | Role | What they receive |
|---|---|---|
| mind body treatment | Experimental | regulation of attention, respiration and posture Receives: Behavioral: mind body treatment |
| desensitization | Active comparator | mentation on insomnia behaviors and cognitive activity Receives: Behavioral: desensitization |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma cortisol
Measured: pretreatment, posttreatment
plasma melatonin
Measured: pretreatment, posttreatment
urinary catecholamines
Measured: pretreatment, posttreatment
heart rate variability
Measured: pretreatment, posttreatment
subjective sleep efficiency
Measured: pretreatment, during treatment, posttreatment, followup
objective sleep efficiency
Measured: pretreatment, posttreatment
Secondary outcomes (5)
actigraphy
Measured: pretreatment, posttreatment
EEG
Measured: pretreatment, posttreatment
subjective mood
Measured: pretreatment, during treatment, posttreatment, followup
depression
Measured: pretreatment, during treatment, posttreatment, followup
anxiety
Measured: pretreatment, during treatment, posttreatment, followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2006 (estimated)
- Study startMar 2006
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Investigators
- Sat Bir S Khalsa, Ph.D., Principal investigator, Brigham and Women's Hospital, Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00303342
- Sponsor's protocol ID
- R01AT002490
- Other IDs
- R01AT002490
- Status last verified
- Jan 2010
- First submitted
- 14 Mar 2006
- Last updated
- 14 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroendocrine Mechanisms in Behavioral Treatment of Insomnia
- ClinicalTrials.gov ID
- NCT00303342
- Acronym / sponsor ID
- R01AT002490
- Conditions
- Insomnia
- Keywords
- sleep, arousal, stress, cortisol, catecholamines
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Mar 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 16 Mar 2006 (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 evaluate the change in measures of physiological arousal before and after behavioral treatment of insomnia.
Detailed description
There is good evidence that physiological arousal, associated with sustained activation of the hypothalamic-pituitary axis and the sympathetic nervous system, is an underlying cause of chronic insomnia. Accordingly, relaxation-related treatments that address elevated cognitive and somatic arousal have been effective for insomnia. Previous studies have documented the effectiveness of behavioral treatments in reducing activation of the hypothalamic-pituitary axis and the sympathetic nervous system and in the treatment of specific medical disorders including insomnia. The aim of this proposal is to evaluate the hypothesis that improvements in chronic psychophysiological insomnia following a behavioral treatment are tightly associated with reduction of arousal in the hypothalamic-pituitary axis, as measured by plasma cortisol, and in the sympathetic nervous system, as measured by urinary catecholamines. Objective measures of sleep will be derived from polysomnographic recordings from subjects randomized into a 10-week active behavioral treatment or placebo behavioral control treatment group. Continuous 24-hour evaluation of cortisol and catecholamines will be performed under controlled laboratory conditions before and after treatment. We anticipate significant reductions in cortisol and catecholamines in the active treatment group as compared with the control group. We also anticipate that the active treatment will yield reductions in related measures of arousal including heart rate, autonomic arousal (as determined from heart rate variability), and body temperature. Given reported evidence that melatonin levels are chronically low in insomnia we anticipate an increase in the sleep-related hormone melatonin in the yoga treatment group. If achieved, these results will provide a novel demonstration of a reduction of arousal in a behavioral insomnia treatment and a behaviorally enhanced melatonin secretion under controlled laboratory conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mind body treatment | Experimental | Behavioral: mind body treatmentregulation of attention, respiration and posture |
| desensitization | Active comparator | Behavioral: desensitizationmentation on insomnia behaviors and cognitive activity |
Who may qualify
- Ages
- 21 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- primary insomnia for 6 months
- average total wake time >60 minutes and sleep efficiency <80%
- at least 1 daytime complaint due to insomnia
- adequate opportunity and circumstance for sleep
Key exclusion criteria (7 listed)
- current psychiatric condition
- medical condition that interferes with sleep
- pregnancy
- rotating shift work, night work or transcontinental travel during study
- anticipated major life stressor over the course of the study
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 |
|---|---|---|
| mind body treatmentregulation of attention, respiration and posture | Behavioural | mind body treatment |
| desensitizationmentation on insomnia behaviors and cognitive activity | Behavioural | desensitization |
Primary outcome
plasma cortisol
Time frame: pretreatment, posttreatment
plasma melatonin
Time frame: pretreatment, posttreatment
urinary catecholamines
Time frame: pretreatment, posttreatment
heart rate variability
Time frame: pretreatment, posttreatment
subjective sleep efficiency
Time frame: pretreatment, during treatment, posttreatment, followup
objective sleep efficiency
Time frame: pretreatment, posttreatment
5 secondary outcomes
actigraphy
Time frame: pretreatment, posttreatment
EEG
Time frame: pretreatment, posttreatment
subjective mood
Time frame: pretreatment, during treatment, posttreatment, followup
depression
Time frame: pretreatment, during treatment, posttreatment, followup
anxiety
Time frame: pretreatment, during treatment, posttreatment, followup
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 14 Jan 2010.
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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.
Sat Bir S Khalsa, Ph.D. principal investigator
Brigham and Women's Hospital, Harvard Medical School
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 mind body treatment and desensitization in people with Insomnia, run by Brigham and Women's Hospital 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 4 inclusion and 7 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 14 Jan 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. 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?
plasma cortisol (time frame: pretreatment, posttreatment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jan 2010.