Sleep Control ConditionNCT02484742
Pain Sensitization and Habituation in a Model of Experimentally-induced Insomnia Symptoms
A study testing Insomnia symptom induction in people with Sleep Control Condition and Insomnia Symptoms Induction Condition, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The main purpose of this study is to learn about the effects of repeated exposure to sleep disruption (3 cycles of sleep disruption, each consisting of three days in a row where sleep is shortened and disrupted, followed by a single night of recovery sleep) on inflammation, mood, and pain processing… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Control Condition, Insomnia Symptoms Induction Condition
- What is being tested?
- Insomnia symptom induction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Mar 2019
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women and men between the ages 18-45 years.
- Body mass index (BMI) between 18.5 and 30 kg/m2.
- For female participants: regular menstrual cycles, no significant discomfort during pre-menses/menses.
- Good quantity/quality sleep
- Blood chemistry in the normal range.
Who cannot join
- - Active infection/disease.
- History of neurological, chronic pain, immune, cardiovascular, liver/kidney, or metabolic disorder.
- History of psychiatric disorders, including major depressive disorders, bipolar disorders, panic disorders, post-traumatic stress disorders (PTSD), thought disorders, and substance abuse/dependence disorders.
- Sleep disorders
- Pregnant/nursing.
- Regular medication use other than oral contraceptives.
- Donation of blood or platelets 3 month prior to or in-between study arms.
Trial locations and contacts
1 site in 1 country.
About this study
The main purpose of this study is to learn about the effects of repeated exposure to sleep disruption (3 cycles of sleep disruption, each consisting of three days in a row where sleep is shortened and disrupted, followed by a single night of recovery sleep) on inflammation, mood, and pain processing (experiences/perceptions of pain). Purpose of this research project is to understand the mechanisms of how sleep disruption may change mood and the experience of pain. Understanding those mechanisms is important to develop interventions that may help to reduce the effects of sleep disruption on mood and pain.
Read the detailed description
- Screening Procedures: For this research study, the screening procedures include the following activities. Participants will first complete questionnaires and have an interview where they will be asked questions concerning general health status and sleep-wake habits. Also during this visit, a study nurse will collect a small blood sample that will be used to test for a number of markers of general health status. If it appears that the participant may be eligible for participation, s/he will be introduced to an electronic diary that will be emailed every morning and evening to monitor sleep-wake patterns, mood, pain, and other health-related information. Following the medical screening (visit 2), the physician will determine if the participant is eligible to proceed to the overnight sleep study. This consists of sleeping overnight in the laboratory during the usual sleep time. Seven days before participation in the in-hospital portion of the study, a member of the study team will ask the participant to follow the study sleep-wake schedule. Sleep will be monitored with an electronic sleep diary and the participant will wear an actigraphy watch, which will help to evaluate sleep and measure the light level exposure before starting the study.
- Randomization Procedures: Each participant will complete both parts of the study protocol, i.e., the experimental condition (where participants will undergo repeated cycles of sleep disruption, 18 days total in the Clinical Research Center) and the control condition (where participants will have a sleep opportunity of 8 hours every night; 18 days total in the Clinical Research Center).
- Research Procedures: If a participant qualifies to take part in this research study, s/he will be required to stay in the hospital for two 18 day long research protocols. These protocols will take place at least 2-3 months apart. The experimental protocol includes 3 nights of 8 hour-sleep per night followed by three 4-day cycles, each consisting of 3 nights of shortened and disrupted sleep, followed by a single night of 8 hour recovery sleep. After the last cycle, the participant will have two more nights with 8 hours of sleep per night. In the control protocol, these 18 days will be 8-hour sleep nights. During the stay in the hospital, research staff will accompany the participant during all waking times. The staff will help the participant to stay on the schedule, maintain wakefulness, and make sure that equipment is recording properly. Both study protocols will begin with two adaptation nights. On the first day of the protocol, the participant will be told the sleep condition to be assigned first: the sleep disruption condition or the sleep control condition. During the sleep disruption nights, sleep onset will be delayed by one hour (midnight 12am), and sleep offset (final wake up) will be advanced by one hour (6am). The sleep period (12-6am) will be disrupted hourly by 20 minute long awakenings. During the nighttime periods, the nurse will measure blood pressure and collect a small sample of your saliva. The participant will also be asked to complete tests that assess well-being and cognitive functioning (such as attention, learning). After the last day of the third cycle, the participant will have four nights with 8 hours of sleep per night. The participant will be able to leave the research center in the morning after the 18th night. During each of the two 18-day stays in the hospital, participants will wear an actigraphy watch on all study days, which will help to evaluate sleep and measure the light level exposure. The participant will also have two blood draws obtained by a simple needle stick on intermittent days. Additionally, during these 24-hour periods, the study team will be collecting sleep recording data (using a polysomnography device over a 24-hour period). Finally, the study team will collect urine samples over the course of this protocol. Blood pressure will be measured at frequent intervals through the study. Computerized performance tests will be conducted at frequent intervals through the study. One of the tests involves measurement of reaction time by having participants press a button on a little box. In another performance test the study team will ask the participant to press the right or left mouse button depending on whether the word on the computer screen is printed in the same color or in a different color; this should be done as quickly and as accurately as possible. In addition, we will ask participants to rate well-being at frequent intervals throughout the stay in the Clinical Research Center. On several days during the stay in the Clinical Research Center, the investigators will test the perception of pain. During pain testing, the participant will remain in a comfortable chair throughout the testing session. The testing will consist of measures of pain threshold (first feeling of the sensation of pain to a heat or mechanical stimulus), pain tolerance (when the pain sensation feels intolerable), and pain modulation (how the central nervous system can change the perception of pain).
- Monitoring/Follow-Up Procedures. For this research study, the monitoring/follow-up procedures include meeting with one of the lead members of the study team on the last day of each of the 18-day protocols. During this time, a study team member will discuss the participant's study experience and will give the opportunity to ask any questions concerning the study.
- Being tested
- Insomnia symptom induction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insomnia symptom inductionBehavioural
Several nights during the 18-day stay will be disrupted, such that we delay sleep onset, advance sleep off set, and the sleep period will be disrupted by frequent nighttime awakenings.
| Study group | Role | What they receive |
|---|---|---|
| Sleep control condition | No intervention | 8 hours of sleep throughout the 18-day stay in the Clinical Research Center |
| Insomnia symptom induction condition | Experimental | 4 4-day cycles, each consisting of 3 nights with sleep disruption followed by one night of recovery sleep. Receives: Behavioral: Insomnia symptom induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory markers
Pro-inflammatory markers including cytokines (IL-6), prostaglandins (PGE2), measured in blood, urine, and saliva
Measured: Followed for the duration of the two in-hospital stays, i.e. 2 x 18 days.
Pain modulation
Sensitivity to heat and pressure pain, capacity to inhibit a painful stimulus when another painful stimuli is applied at the same time
Measured: Followed for the duration of the two in-hospital stays, i.e. 2 x 18 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionMar 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sleep Control ConditionStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monika Haack, Beth Israel Deaconess Medical Center
- Investigators
- Monika Haack, PhD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02484742
- Sponsor's protocol ID
- 2014P000354
- Status last verified
- Jul 2019
- First submitted
- 16 Jun 2015
- Last updated
- 9 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Engert LC, Mullington JM, Haack M. Prolonged experimental sleep disturbance affects the inflammatory resolution pathways in healthy humans. Brain Behav Immun. 2023 Oct;113:12-20. doi: 10.1016/j.bbi.2023.06.018. Epub 2023 Jun 25.
PubMed 37369338Haack M, Engert LC, Besedovsky L, Goldstein MR, Devine JK, Dang R, Olia K, Molina V, Bertisch SM, Sethna N, Simpson N. Alterations of pain pathways by experimental sleep disturbances in humans: central pain-inhibitory, cyclooxygenase, and endocannabinoid pathways. Sleep. 2023 Jun 13;46(6):zsad061. doi: 10.1093/sleep/zsad061.
PubMed 36881901
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Sensitization and Habituation in a Model of Experimentally-induced Insomnia Symptoms
- ClinicalTrials.gov ID
- NCT02484742
- Acronym / sponsor ID
- 2014P000354
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 30 Jun 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.
The main purpose of this study is to learn about the effects of repeated exposure to sleep disruption (3 cycles of sleep disruption, each consisting of three days in a row where sleep is shortened and disrupted, followed by a single night of recovery sleep) on inflammation, mood, and pain processing (experiences/perceptions of pain). Purpose of this research project is to understand the mechanisms of how sleep disruption may change mood and the experience of pain. Understanding those mechanisms is important to develop interventions that may help to reduce the effects of sleep disruption on mood and pain.
Detailed description
- Screening Procedures: For this research study, the screening procedures include the following activities. Participants will first complete questionnaires and have an interview where they will be asked questions concerning general health status and sleep-wake habits. Also during this visit, a study nurse will collect a small blood sample that will be used to test for a number of markers of general health status. If it appears that the participant may be eligible for participation, s/he will be introduced to an electronic diary that will be emailed every morning and evening to monitor sleep-wake patterns, mood, pain, and other health-related information. Following the medical screening (visit 2), the physician will determine if the participant is eligible to proceed to the overnight sleep study. This consists of sleeping overnight in the laboratory during the usual sleep time. Seven days before participation in the in-hospital portion of the study, a member of the study team will ask the participant to follow the study sleep-wake schedule. Sleep will be monitored with an electronic sleep diary and the participant will wear an actigraphy watch, which will help to evaluate sleep and measure the light level exposure before starting the study.
- Randomization Procedures: Each participant will complete both parts of the study protocol, i.e., the experimental condition (where participants will undergo repeated cycles of sleep disruption, 18 days total in the Clinical Research Center) and the control condition (where participants will have a sleep opportunity of 8 hours every night; 18 days total in the Clinical Research Center).
- Research Procedures: If a participant qualifies to take part in this research study, s/he will be required to stay in the hospital for two 18 day long research protocols. These protocols will take place at least 2-3 months apart. The experimental protocol includes 3 nights of 8 hour-sleep per night followed by three 4-day cycles, each consisting of 3 nights of shortened and disrupted sleep, followed by a single night of 8 hour recovery sleep. After the last cycle, the participant will have two more nights with 8 hours of sleep per night. In the control protocol, these 18 days will be 8-hour sleep nights. During the stay in the hospital, research staff will accompany the participant during all waking times. The staff will help the participant to stay on the schedule, maintain wakefulness, and make sure that equipment is recording properly. Both study protocols will begin with two adaptation nights. On the first day of the protocol, the participant will be told the sleep condition to be assigned first: the sleep disruption condition or the sleep control condition. During the sleep disruption nights, sleep onset will be delayed by one hour (midnight 12am), and sleep offset (final wake up) will be advanced by one hour (6am). The sleep period (12-6am) will be disrupted hourly by 20 minute long awakenings. During the nighttime periods, the nurse will measure blood pressure and collect a small sample of your saliva. The participant will also be asked to complete tests that assess well-being and cognitive functioning (such as attention, learning). After the last day of the third cycle, the participant will have four nights with 8 hours of sleep per night. The participant will be able to leave the research center in the morning after the 18th night. During each of the two 18-day stays in the hospital, participants will wear an actigraphy watch on all study days, which will help to evaluate sleep and measure the light level exposure. The participant will also have two blood draws obtained by a simple needle stick on intermittent days. Additionally, during these 24-hour periods, the study team will be collecting sleep recording data (using a polysomnography device over a 24-hour period). Finally, the study team will collect urine samples over the course of this protocol. Blood pressure will be measured at frequent intervals through the study. Computerized performance tests will be conducted at frequent intervals through the study. One of the tests involves measurement of reaction time by having participants press a button on a little box. In another performance test the study team will ask the participant to press the right or left mouse button depending on whether the word on the computer screen is printed in the same color or in a different color; this should be done as quickly and as accurately as possible. In addition, we will ask participants to rate well-being at frequent intervals throughout the stay in the Clinical Research Center. On several days during the stay in the Clinical Research Center, the investigators will test the perception of pain. During pain testing, the participant will remain in a comfortable chair throughout the testing session. The testing will consist of measures of pain threshold (first feeling of the sensation of pain to a heat or mechanical stimulus), pain tolerance (when the pain sensation feels intolerable), and pain modulation (how the central nervous system can change the perception of pain).
- Monitoring/Follow-Up Procedures. For this research study, the monitoring/follow-up procedures include meeting with one of the lead members of the study team on the last day of each of the 18-day protocols. During this time, a study team member will discuss the participant's study experience and will give the opportunity to ask any questions concerning the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep control condition | No intervention | –8 hours of sleep throughout the 18-day stay in the Clinical Research Center |
| Insomnia symptom induction condition | Experimental | Behavioral: Insomnia symptom induction4 4-day cycles, each consisting of 3 nights with sleep disruption followed by one night of recovery sleep. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women and men between the ages 18-45 years.
- Body mass index (BMI) between 18.5 and 30 kg/m2.
- For female participants: regular menstrual cycles, no significant discomfort during pre-menses/menses.
- Good quantity/quality sleep
- Blood chemistry in the normal range.
Key exclusion criteria (7 listed)
- - Active infection/disease.
- History of neurological, chronic pain, immune, cardiovascular, liver/kidney, or metabolic disorder.
- History of psychiatric disorders, including major depressive disorders, bipolar disorders, panic disorders, post-traumatic stress disorders (PTSD), thought disorders, and substance abuse/dependence disorders.
- Sleep disorders
- Pregnant/nursing.
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 |
|---|---|---|
| Insomnia symptom inductionSeveral nights during the 18-day stay will be disrupted, such that we delay sleep onset, advance sleep off set, and the sleep period will be disrupted by frequent nighttime awakenings. | Behavioural | Insomnia symptom induction condition |
Primary outcome
Inflammatory markers
Time frame: Followed for the duration of the two in-hospital stays, i.e. 2 x 18 days.
Pro-inflammatory markers including cytokines (IL-6), prostaglandins (PGE2), measured in blood, urine, and saliva
Pain modulation
Time frame: Followed for the duration of the two in-hospital stays, i.e. 2 x 18 days.
Sensitivity to heat and pressure pain, capacity to inhibit a painful stimulus when another painful stimuli is applied at the same time
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 9 Jul 2019.
- Derived from this study: PubMed 37369338Engert LC, Mullington JM, Haack M. Prolonged experimental sleep disturbance affects the inflammatory resolution pathways in healthy humans. Brain Behav Immun. 2023 Oct;113:12-20. doi: 10.1016/j.bbi.2023.06.018. Epub 2023 Jun 25.
- Derived from this study: PubMed 36881901Haack M, Engert LC, Besedovsky L, Goldstein MR, Devine JK, Dang R, Olia K, Molina V, Bertisch SM, Sethna N, Simpson N. Alterations of pain pathways by experimental sleep disturbances in humans: central pain-inhibitory, cyclooxygenase, and endocannabinoid pathways. Sleep. 2023 Jun 13;46(6):zsad061. doi: 10.1093/sleep/zsad061.
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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.
Monika Haack, PhD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insomnia symptom induction in people with Sleep Control Condition and Insomnia Symptoms Induction Condition, run by Beth Israel Deaconess Medical Center 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 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 9 Jul 2019. 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?
Inflammatory markers (time frame: Followed for the duration of the two in-hospital stays, i.e. 2 x 18 days.). The study lists 2 primary outcomes in all. 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 NCT02484742, which also lists 2 linked publications.
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 9 Jul 2019.