Primary InsomniaNCT02443649
Improving Sleep Quality in People With Insomnia
A study testing Sleep hygiene program and Sleep hypnosis in people with Primary Insomnia and Psychophysiological Insomnia, run by Oregon Health and Science University at 1 site in United States.
Trial summary
Insomnia is a significant problem affecting 10 to 20% of US population. Long-term pharmacological treatments are not recommended due to side effects, with therapy and sleep hygiene education often employed as alternatives. Use of mind-body approaches for insomnia is increasing. Read more about this study
- Who is it for?
- Ages 25 to 85 years
- Conditions the study is for
- Primary Insomnia, Psychophysiological Insomnia
- What is being tested?
- Sleep hygiene program and Sleep hypnosis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Dec 2016
- Phase
- Interventional
- 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 25 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 25 or older
- Primary insomnia diagnosis
- Able to attend all study sessions and willing to complete the study requirements
- Fluent English
- Able and willing to consent
Who cannot join
- Current use of hypnosis with hypnotist
- Other diagnosed sleep disorders
- Other serious illness (e.g. cancer, major depression, chronic pain condition etc.)
- Problem hearing
- Pregnancy
- Use of illicit drugs or alcohol use in excess of what constitutes moderate drinking (>1 drink per day for women and >2 drinks per day for men)
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Insomnia is a significant problem affecting 10 to 20% of US population. Long-term pharmacological treatments are not recommended due to side effects, with therapy and sleep hygiene education often employed as alternatives. Use of mind-body approaches for insomnia is increasing. One of the most promising mind-body approaches for alleviating sleep problems is hypnosis. Research indicates significant beneficial effects of hypnosis on sleep, but sleep was rarely assessed as primary outcome and studied populations were diverse. Further, it remains unclear who the best candidates for benefitting from hypnosis are. To address some of the gaps in the current knowledge, the study evaluates whether 1) an addition of hypnotic suggestion for sleep improvement to the optimizing sleep hygiene (OSH) program increases the effectiveness of the OSH using objective and subjective assessments and 2) determines characteristics associated with hypnotic responsiveness.To address these goals a randomized controlled trial (RCT) with 3 laboratory visits (baseline, intervention, and 1 month follow-up) will be conducted with 50 adults meeting criteria for primary insomnia and allocated to one the two groups: 1) experimental group receiving during the intervention visit a combination of the Optimizing Sleep Hygiene (OSH) program and a hypnosis session for sleep improvement and 2) a control group receiving at the intervention visit the OSH only. Hypnosis session for sleep improvement for the control group will be offered at the end of the follow-up study visit (conducted after 4 weeks post-intervention) after completing all follow-up measures. Each study visit will last for 2-3 hours. During the visits sleep, personality traits and daily function of the participants will be assessed. Further, after the baseline and one week before the follow-up visit subjects will wear a watch-like actigraphic device monitoring their sleep patterns at home and will complete sleep diary.
The knowledge gained from this study will inform the literature and clinicians about usefulness of hypnosis for insomnia sufferers and will help identify the population of insomnia sufferers most likely benefit from use of hypnosis for sleep
Read the detailed description
- Protocol Title Improving sleep quality in people with insomnia
- Objectives The purpose of the study is to compare effectiveness of two sleep improvement programs for people with primary psychophysiological insomnia: 1) the Optimizing Sleep Hygiene (OSH) program and 2) a combination of the OSH and hypnosis for sleep improvement. The goals of this study are: 1) using objective and subjective assessments to evaluate whether an addition of hypnotic suggestion for sleep improvement to the sleep hygiene program increases the effectiveness of the OSH, and 2) to determine subject characteristics associated with hypnotic responsiveness in adults with primary psychophysiological insomnia. To address these goals a randomized controlled trial (RCT) with 3 laboratory visits (baseline, intervention, and 1-month follow-up) will be conducted with 50 adults meeting criteria for psychophysiological insomnia and allocated to one the two groups: 1) experimental group receiving during the intervention visit a combination of the Optimizing Sleep Hygiene (OSH) program and a hypnosis session for sleep improvement and 2) a control group receiving at the intervention visit the OSH only. One-month follow-up visit will be conducted following at least 4 weeks since the intervention visit. Hypnosis session for sleep improvement for the control group will be offered at the end of the follow-up study visit after completing all follow-up measures. Each study visit will last for 2-3 hours. During the visits participants' personality traits, hypnotic susceptibility as well as measures of insomnia severity, sleep quality, hygiene, and daily function will be assessed. Further, between the visits at home subjects will wear a watch-like actigraphic device monitoring their day and night activity. These actigraphic recordings will allow for collecting objective actigraphic measures of sleep. The actigraphic measures will be collected along with daily sleep and medications diaries for periods of 7 days immediately after the baseline assessment and 1 week prior to one-month follow-up assessment. Additionally, during the one-month follow-up visit, patterns of brain activity will be monitored in all subjects first when they listen to a neutral sleep-related recording and then during listening to a recording of hypnosis for sleep improvement. The purpose of these measures is to compare brain activity patterns and identify specific biomarkers of hypnotic state. Four weeks after the completion of all study visits participants will provide information about their sleep and their experiences with the study interventions components via a telephone or on-line assessment depending on their choice.The knowledge gained from this study will inform the literature and clinicians about usefulness of hypnosis for insomnia sufferers and will help identify the population most likely benefit from use of hypnosis for sleep. The goals of the proposal will be addressed by the following specific aims: Specific Aim 1: Compare changes from baseline in sleep parameters at the one-month follow-up visit between the two study groups (experimental and control) after exposure to the interventions. Hypothesis: Greater improvements in actigraphic and subjective sleep parameters and daily function will be observed in the experimental group compared to the control group. Specific Aim 2a: Identify characteristics correlating with changes in measures of sleep quality to describe a population that can potentially benefit from hypnosis. Hypothesis: Several sleep-specific variables (e.g. specific baseline insomnia symptoms and sleep hygiene problems) and personality features (e.g. hypnotic susceptibility and specific personality traits) will correlate with post-intervention changes in sleep variables. Specific Aim 2b: Identify characteristics correlating with hypnotic susceptibility for creating a scale that can be used in a clinic to assess hypnotic responsiveness for sleep-related problems. Hypothesis: Using the items from the instruments given during the study identified as a part of Specific Aim 2a short instrument could be constructed that can quickly and reliably categorize people based on their hypnotic responsiveness for sleep-related problems. Specific Aim 3: Assess brain wave patterns concurrent with hypnosis to identify psychophysiological markers specific to hypnotic state in order to describe mechanisms underlying hypnosis. Hypothesis: Based on the differences between the two states: 1) listening to hypnosis and 2) listening to a neutral sleep-related recording, brain activity markers that can distinguish state of hypnosis from the state of listening to a neutral recording could be identified. Background Insomnia, characterized by non-restorative sleep or by difficulty in initiating or maintaining sleep, is a significant problem affecting 10 to 20% of US population. Poor sleep impairs cognitive and immune functions, mood and productivity of sufferers and can increase risk for hypertension, diabetes, cancer and overall mortality. Long-term pharmacological insomnia treatment is not recommended due to side effects, with therapy and sleep hygiene education often employed as alternatives. There is also a growing interest in using mind-body approaches for managing sleep problems. Mind-body approaches are becoming popular due to accessibility and low side effect profile, as well as due to increasing amount of research evidence indicating their effectiveness. For example, a recent review of mind-body methods for improving sleep revealed that among the most promising mind-body approaches for alleviating sleep problems was hypnosis. Hypnosis is a state of relaxation combined with highly focused attention and characterized by dissociation of competing thoughts and sensations towards the periphery of awareness. One way to achieve hypnotic state is through an induction procedure typically followed by hypnotic suggestions or statements intended to elicit behavioral change. Efficacy of hypnosis has been demonstrated for several conditions, most notably for decreasing pain and alleviating stress-related disorders. Using hypnosis for sleep improvement is still a developing area of research. Though several studies found significant beneficial effects of hypnosis on sleep, most studies used hypnosis for alleviating other problems influencing sleep (e.g. hot flashes) rather than specifically targeting sleep as the primary focus of improvement. Moreover, majority of the studies on sleep and hypnosis used only subjective measures for evaluating sleep quality. Further, it remains unclear who the best candidates for benefitting from hypnosis are and how hypnotic responsiveness can be assessed in a clinic without lengthy tests of hypnotic susceptibility. To address some of the gaps in the current knowledge, the goals of this study are: 1) using objective and subjective assessments to evaluate whether an addition of hypnotic suggestion for sleep improvement to the sleep hygiene education program increases the program effectiveness, and 2) to determine subject characteristics associated with hypnotic responsiveness in adults with primary psychophysiological insomnia.
- Design: The planned study is a single-blind two-arm randomized controlled trial (RCT) with three study visits (baseline, intervention, and one-month follow-up), with participants randomly assigned to receive Optimizing Sleep Hygiene (OSH) program as an intervention either alone or in conjunction with hypnosis for sleep improvement during the intervention visit.
- Conditions
- Primary Insomnia, Psychophysiological Insomnia
- Being tested
- Sleep hygiene program, Sleep hypnosis
- 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.
Sleep hygiene programBehavioural
Sleep hygiene program
Sleep hypnosisBehavioural
Also called Hypnosis
Hypnosis recording with personalized goals and imagery for sleep improvement
| Study group | Role | What they receive |
|---|---|---|
| Sleep hypnosis plus sleep hygiene | Experimental | Those randomized into this group will receive the sleep hygiene program plus hypnosis. Receives: Behavioral: Sleep hygiene program; Behavioral: Sleep hypnosis |
| Sleep hygiene only | Active comparator | Those randomized into this group will receive the Optimizing Sleep Hygiene program during the intervention visit and hypnosis recording after the follow-up visit. Receives: Behavioral: Sleep hygiene program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep efficiency change at one-month follow-up (from baseline)
actigraphic sleep efficiency
Measured: collected at baseline and one-month follow-up
Secondary outcomes (2)
Functional outcomes of sleep score change at one-month follow-up (from baseline)
Functional outcomes of sleep score collected at baseline and follow-up through FOSQ
Measured: collected at baseline and one-month follow-up
Sleep Hygiene score change at one-month follow-up (from baseline)
Sleep Hygiene Index instrument score
Measured: collected at baseline and one-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary InsomniaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barry S. Oken, Oregon Health and Science University
- Investigators
- Barry S Oken, MD, MS, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02443649
- Sponsor's protocol ID
- IRB#10810
- Status last verified
- Dec 2016
- First submitted
- 10 Mar 2015
- Last updated
- 15 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Sleep Quality in People With Insomnia
- ClinicalTrials.gov ID
- NCT02443649
- Acronym / sponsor ID
- IRB#10810
- Conditions
- Primary Insomnia, Psychophysiological Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 14 May 2015 (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.
Insomnia is a significant problem affecting 10 to 20% of US population. Long-term pharmacological treatments are not recommended due to side effects, with therapy and sleep hygiene education often employed as alternatives. Use of mind-body approaches for insomnia is increasing. One of the most promising mind-body approaches for alleviating sleep problems is hypnosis. Research indicates significant beneficial effects of hypnosis on sleep, but sleep was rarely assessed as primary outcome and studied populations were diverse. Further, it remains unclear who the best candidates for benefitting from hypnosis are. To address some of the gaps in the current knowledge, the study evaluates whether 1) an addition of hypnotic suggestion for sleep improvement to the optimizing sleep hygiene (OSH) program increases the effectiveness of the OSH using objective and subjective assessments and 2) determines characteristics associated with hypnotic responsiveness.To address these goals a randomized controlled trial (RCT) with 3 laboratory visits (baseline, intervention, and 1 month follow-up) will be conducted with 50 adults meeting criteria for primary insomnia and allocated to one the two groups: 1) experimental group receiving during the intervention visit a combination of the Optimizing Sleep Hygiene (OSH) program and a hypnosis session for sleep improvement and 2) a control group receiving at the intervention visit the OSH only. Hypnosis session for sleep improvement for the control group will be offered at the end of the follow-up study visit (conducted after 4 weeks post-intervention) after completing all follow-up measures. Each study visit will last for 2-3 hours. During the visits sleep, personality traits and daily function of the participants will be assessed. Further, after the baseline and one week before the follow-up visit subjects will wear a watch-like actigraphic device monitoring their sleep patterns at home and will complete sleep diary.
The knowledge gained from this study will inform the literature and clinicians about usefulness of hypnosis for insomnia sufferers and will help identify the population of insomnia sufferers most likely benefit from use of hypnosis for sleep
Detailed description
- Protocol Title Improving sleep quality in people with insomnia
- Objectives The purpose of the study is to compare effectiveness of two sleep improvement programs for people with primary psychophysiological insomnia: 1) the Optimizing Sleep Hygiene (OSH) program and 2) a combination of the OSH and hypnosis for sleep improvement. The goals of this study are: 1) using objective and subjective assessments to evaluate whether an addition of hypnotic suggestion for sleep improvement to the sleep hygiene program increases the effectiveness of the OSH, and 2) to determine subject characteristics associated with hypnotic responsiveness in adults with primary psychophysiological insomnia. To address these goals a randomized controlled trial (RCT) with 3 laboratory visits (baseline, intervention, and 1-month follow-up) will be conducted with 50 adults meeting criteria for psychophysiological insomnia and allocated to one the two groups: 1) experimental group receiving during the intervention visit a combination of the Optimizing Sleep Hygiene (OSH) program and a hypnosis session for sleep improvement and 2) a control group receiving at the intervention visit the OSH only. One-month follow-up visit will be conducted following at least 4 weeks since the intervention visit. Hypnosis session for sleep improvement for the control group will be offered at the end of the follow-up study visit after completing all follow-up measures. Each study visit will last for 2-3 hours. During the visits participants' personality traits, hypnotic susceptibility as well as measures of insomnia severity, sleep quality, hygiene, and daily function will be assessed. Further, between the visits at home subjects will wear a watch-like actigraphic device monitoring their day and night activity. These actigraphic recordings will allow for collecting objective actigraphic measures of sleep. The actigraphic measures will be collected along with daily sleep and medications diaries for periods of 7 days immediately after the baseline assessment and 1 week prior to one-month follow-up assessment. Additionally, during the one-month follow-up visit, patterns of brain activity will be monitored in all subjects first when they listen to a neutral sleep-related recording and then during listening to a recording of hypnosis for sleep improvement. The purpose of these measures is to compare brain activity patterns and identify specific biomarkers of hypnotic state. Four weeks after the completion of all study visits participants will provide information about their sleep and their experiences with the study interventions components via a telephone or on-line assessment depending on their choice.The knowledge gained from this study will inform the literature and clinicians about usefulness of hypnosis for insomnia sufferers and will help identify the population most likely benefit from use of hypnosis for sleep. The goals of the proposal will be addressed by the following specific aims: Specific Aim 1: Compare changes from baseline in sleep parameters at the one-month follow-up visit between the two study groups (experimental and control) after exposure to the interventions. Hypothesis: Greater improvements in actigraphic and subjective sleep parameters and daily function will be observed in the experimental group compared to the control group. Specific Aim 2a: Identify characteristics correlating with changes in measures of sleep quality to describe a population that can potentially benefit from hypnosis. Hypothesis: Several sleep-specific variables (e.g. specific baseline insomnia symptoms and sleep hygiene problems) and personality features (e.g. hypnotic susceptibility and specific personality traits) will correlate with post-intervention changes in sleep variables. Specific Aim 2b: Identify characteristics correlating with hypnotic susceptibility for creating a scale that can be used in a clinic to assess hypnotic responsiveness for sleep-related problems. Hypothesis: Using the items from the instruments given during the study identified as a part of Specific Aim 2a short instrument could be constructed that can quickly and reliably categorize people based on their hypnotic responsiveness for sleep-related problems. Specific Aim 3: Assess brain wave patterns concurrent with hypnosis to identify psychophysiological markers specific to hypnotic state in order to describe mechanisms underlying hypnosis. Hypothesis: Based on the differences between the two states: 1) listening to hypnosis and 2) listening to a neutral sleep-related recording, brain activity markers that can distinguish state of hypnosis from the state of listening to a neutral recording could be identified. Background Insomnia, characterized by non-restorative sleep or by difficulty in initiating or maintaining sleep, is a significant problem affecting 10 to 20% of US population. Poor sleep impairs cognitive and immune functions, mood and productivity of sufferers and can increase risk for hypertension, diabetes, cancer and overall mortality. Long-term pharmacological insomnia treatment is not recommended due to side effects, with therapy and sleep hygiene education often employed as alternatives. There is also a growing interest in using mind-body approaches for managing sleep problems. Mind-body approaches are becoming popular due to accessibility and low side effect profile, as well as due to increasing amount of research evidence indicating their effectiveness. For example, a recent review of mind-body methods for improving sleep revealed that among the most promising mind-body approaches for alleviating sleep problems was hypnosis. Hypnosis is a state of relaxation combined with highly focused attention and characterized by dissociation of competing thoughts and sensations towards the periphery of awareness. One way to achieve hypnotic state is through an induction procedure typically followed by hypnotic suggestions or statements intended to elicit behavioral change. Efficacy of hypnosis has been demonstrated for several conditions, most notably for decreasing pain and alleviating stress-related disorders. Using hypnosis for sleep improvement is still a developing area of research. Though several studies found significant beneficial effects of hypnosis on sleep, most studies used hypnosis for alleviating other problems influencing sleep (e.g. hot flashes) rather than specifically targeting sleep as the primary focus of improvement. Moreover, majority of the studies on sleep and hypnosis used only subjective measures for evaluating sleep quality. Further, it remains unclear who the best candidates for benefitting from hypnosis are and how hypnotic responsiveness can be assessed in a clinic without lengthy tests of hypnotic susceptibility. To address some of the gaps in the current knowledge, the goals of this study are: 1) using objective and subjective assessments to evaluate whether an addition of hypnotic suggestion for sleep improvement to the sleep hygiene education program increases the program effectiveness, and 2) to determine subject characteristics associated with hypnotic responsiveness in adults with primary psychophysiological insomnia.
- Design: The planned study is a single-blind two-arm randomized controlled trial (RCT) with three study visits (baseline, intervention, and one-month follow-up), with participants randomly assigned to receive Optimizing Sleep Hygiene (OSH) program as an intervention either alone or in conjunction with hypnosis for sleep improvement during the intervention visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep hypnosis plus sleep hygiene | Experimental | Behavioral: Sleep hygiene program, Behavioral: Sleep hypnosisThose randomized into this group will receive the sleep hygiene program plus hypnosis. |
| Sleep hygiene only | Active comparator | Behavioral: Sleep hygiene programThose randomized into this group will receive the Optimizing Sleep Hygiene program during the intervention visit and hypnosis recording after the follow-up visit. |
Who may qualify
- Ages
- 25 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 25 or older
- Primary insomnia diagnosis
- Able to attend all study sessions and willing to complete the study requirements
- Fluent English
- Able and willing to consent
Key exclusion criteria (6 listed)
- Current use of hypnosis with hypnotist
- Other diagnosed sleep disorders
- Other serious illness (e.g. cancer, major depression, chronic pain condition etc.)
- Problem hearing
- Pregnancy
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 |
|---|---|---|
| Sleep hygiene programSleep hygiene program | Behavioural | Sleep hygiene only, Sleep hypnosis plus sleep hygiene |
| Sleep hypnosisAlso: HypnosisHypnosis recording with personalized goals and imagery for sleep improvement | Behavioural | Sleep hypnosis plus sleep hygiene |
Primary outcome
Sleep efficiency change at one-month follow-up (from baseline)
Time frame: collected at baseline and one-month follow-up
actigraphic sleep efficiency
2 secondary outcomes
Functional outcomes of sleep score change at one-month follow-up (from baseline)
Time frame: collected at baseline and one-month follow-up
Sleep Hygiene score change at one-month follow-up (from baseline)
Time frame: collected at baseline and one-month follow-up
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 15 Dec 2016.
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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.
Barry S Oken, MD, MS principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep hygiene program and Sleep hypnosis in people with Primary Insomnia and Psychophysiological Insomnia, run by Oregon Health and Science University 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 5 inclusion and 6 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 15 Dec 2016. 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.
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 efficiency change at one-month follow-up (from baseline) (time frame: collected at baseline and one-month follow-up). 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 15 Dec 2016.