Posttraumatic Stress DisorderNCT03487991
Stress, Sleep and Cardiovascular Risk
A study testing Personalized sleep intervention in people with Posttraumatic Stress Disorder and Insomnia, run by Howard University at 1 site in United States.
Trial summary
We are evaluating a model where trauma exposure and threatening environments elicit nocturnal vigilance and sleep-related fears that compromise the healthy reduction of autonomic arousal during sleep which in turn stimulates secretion of atherogenic humoral factors, arterial stiffening, and cardiovascular disease… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Posttraumatic Stress Disorder, Insomnia
- What is being tested?
- Personalized sleep intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2017to 31 Oct 2021
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- current medical or psychiatric condition that affects sleep or requires daily - use of medication other than PTSD, phobic disorders, or past history of major depression
- severe alcohol or drug use disorders
- overnight shift worker or an extreme chronotype
- sleep disorder other than insomnia or nightmares
- morbid obesity (body mass index > 40)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Clinical Research Unit; Howard University Hospital
Washington D.C., District of Columbia, 20060
Alice Ukaegbu, DMP MSN, 202-865-7276, aukaegbu@howard.edu
Obisesan Yejide, BA, 202-806-7818, yejide.obisesan@howard.edu
About this study
We are evaluating a model where trauma exposure and threatening environments elicit nocturnal vigilance and sleep-related fears that compromise the healthy reduction of autonomic arousal during sleep which in turn stimulates secretion of atherogenic humoral factors, arterial stiffening, and cardiovascular disease risk. We will examine the roles of pre-sleep cognition using a questionnaire and real time assessment, and modifiable strategies for coping with sleep disruptive cognitions. We will then evaluate the impact of providing personalized feedback and recommendations based on study observations on how participants cope with potentially sleep disruptive cognitions and sleep efficiency in a randomized trial.
Read the detailed description
The study has 3 specific aims.
Aim 1. To confirm the effects of neighborhood and posttraumatic stress, and nocturnal vigilance on nocturnal autonomic balance determined by complementary biomarkers.
Hypothesis 1a - Neighborhood disorder and posttraumatic stress symptom severity will be inversely correlated with indicators of autonomic balance derived from analyses of heart rate variability and cardiac impedence, and nocturnal/evening urinary noradrenergic excretion ratios.
Hypothesis 1b - These relationships will be partially or fully accounted for by nocturnal vigilance and the frequency and intensity of pre-sleep disruptive cognitions assessed in real time, and strategies for coping with sleep disruptive thoughts.
Aim 2. To determine relationships of nocturnal autonomic activity to biomarkers of inflammation and endothelial dysfunction.
Hypothesis 2 - Indicators of nocturnal autonomic balance will correlate with morning levels of pro-inflammatory cytokines and adhesion molecules; and pulse wave velocity.
Aim 3. To determine if sleep is improved 6 months after receiving personalized recommendations for adaptively modifying sleep-related behaviors, and if improved sleep and reduced pre-sleep cognitive arousal are associated with more favorable nocturnal autonomic balance and endothelial function.
Hypothesis 3a - Reduced frequency and intensity of sleep disruptive cognitions and improved sleep efficiency will be more likely in the group that received personalized feedback and recommendations for sleep.
Hypothesis 3b - Reduction of disruptive pre-sleep cognitions, and increased sleep efficiency will be associated with improved autonomic status at night and a more favorable profile of cardiovascular risk biomarkers.
- Conditions
- Posttraumatic Stress Disorder, Insomnia
- Being tested
- Personalized sleep intervention
- Keywords
- autonomic balance, sleep, endothelial function, behavior, stress
- Medical subject headings
- Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized sleep interventionBehavioural
Personalized feedback and recommendations based on study observations of sleep behavior and how participants cope with potentially sleep disruptive cognitions on their frequency and impact and on sleep efficiency. A written report is provided to participants and their initial modifications are monitored.
| Study group | Role | What they receive |
|---|---|---|
| personalized behavioral recommendations | Experimental | Will receive recommendations for altering sleep related behavior based on data from in-home monitoring. Receives: Behavioral: Personalized sleep intervention |
| educational control | No intervention | Will receive the data without recommendations. Will receive personalized recommendations after the follow up assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
sleep efficiency
percent of time in bed spent asleep
Measured: 6 months
Secondary outcomes (2)
normalized high frequency ratio of heart rate variability while in bed
an index of parasympathetic nervous system activity
Measured: 6 months
pulse wave velocity
a measure of arterial elasticity
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2018
- Study start1 Oct 2017
- Primary completion31 Oct 2021 (estimated)
- Study completion31 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Howard University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03487991
- Sponsor's protocol ID
- 1R01HL136626-01
- Status last verified
- Mar 2018
- First submitted
- 28 Mar 2018
- Last updated
- 4 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress, Sleep and Cardiovascular Risk
- ClinicalTrials.gov ID
- NCT03487991
- Acronym / sponsor ID
- 1R01HL136626-01
- Conditions
- Posttraumatic Stress Disorder, Insomnia
- Keywords
- autonomic balance, sleep, endothelial function, behavior, stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Howard UniversityUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 4 Apr 2018 (actual)
- 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.
We are evaluating a model where trauma exposure and threatening environments elicit nocturnal vigilance and sleep-related fears that compromise the healthy reduction of autonomic arousal during sleep which in turn stimulates secretion of atherogenic humoral factors, arterial stiffening, and cardiovascular disease risk. We will examine the roles of pre-sleep cognition using a questionnaire and real time assessment, and modifiable strategies for coping with sleep disruptive cognitions. We will then evaluate the impact of providing personalized feedback and recommendations based on study observations on how participants cope with potentially sleep disruptive cognitions and sleep efficiency in a randomized trial.
Detailed description
The study has 3 specific aims.
Aim 1. To confirm the effects of neighborhood and posttraumatic stress, and nocturnal vigilance on nocturnal autonomic balance determined by complementary biomarkers.
Hypothesis 1a - Neighborhood disorder and posttraumatic stress symptom severity will be inversely correlated with indicators of autonomic balance derived from analyses of heart rate variability and cardiac impedence, and nocturnal/evening urinary noradrenergic excretion ratios.
Hypothesis 1b - These relationships will be partially or fully accounted for by nocturnal vigilance and the frequency and intensity of pre-sleep disruptive cognitions assessed in real time, and strategies for coping with sleep disruptive thoughts.
Aim 2. To determine relationships of nocturnal autonomic activity to biomarkers of inflammation and endothelial dysfunction.
Hypothesis 2 - Indicators of nocturnal autonomic balance will correlate with morning levels of pro-inflammatory cytokines and adhesion molecules; and pulse wave velocity.
Aim 3. To determine if sleep is improved 6 months after receiving personalized recommendations for adaptively modifying sleep-related behaviors, and if improved sleep and reduced pre-sleep cognitive arousal are associated with more favorable nocturnal autonomic balance and endothelial function.
Hypothesis 3a - Reduced frequency and intensity of sleep disruptive cognitions and improved sleep efficiency will be more likely in the group that received personalized feedback and recommendations for sleep.
Hypothesis 3b - Reduction of disruptive pre-sleep cognitions, and increased sleep efficiency will be associated with improved autonomic status at night and a more favorable profile of cardiovascular risk biomarkers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| personalized behavioral recommendations | Experimental | Behavioral: Personalized sleep interventionWill receive recommendations for altering sleep related behavior based on data from in-home monitoring. |
| educational control | No intervention | –Will receive the data without recommendations. Will receive personalized recommendations after the follow up assessment. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- current medical or psychiatric condition that affects sleep or requires daily - use of medication other than PTSD, phobic disorders, or past history of major depression
- severe alcohol or drug use disorders
- overnight shift worker or an extreme chronotype
- sleep disorder other than insomnia or nightmares
- morbid obesity (body mass index > 40)
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 |
|---|---|---|
| Personalized sleep interventionPersonalized feedback and recommendations based on study observations of sleep behavior and how participants cope with potentially sleep disruptive cognitions on their frequency and impact and on sleep efficiency. A written report is provided to participants and their initial modifications are monitored. | Behavioural | personalized behavioral recommendations |
Primary outcome
sleep efficiency
Time frame: 6 months
percent of time in bed spent asleep
2 secondary outcomes
normalized high frequency ratio of heart rate variability while in bed
Time frame: 6 months
pulse wave velocity
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized sleep intervention in people with Posttraumatic Stress Disorder and Insomnia, run by Howard 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 0 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 4 Apr 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Travan Hurst, BA (202-865-7267, TLHurst@Howard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sleep efficiency (time frame: 6 months). 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 4 Apr 2018.