InsomniaEarly Phase 1NCT02268565
Preventing the Inflammatory Response to Experimentally-induced Insomnia Symptoms
A Early Phase 1 study testing Aspirin in people with Insomnia, 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 sleep disruption (two days in a row where sleep is shortened and disrupted) on inflammation, mood (how you feel), and pain processing (your own experiences/perceptions of pain). Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia
- What is being tested?
- Aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Dec 2016
- Phase
- Early Phase 1
- 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
- Women and men between the ages 18-35 years
- Body mass index (BMI) between 18.5 and 30.0 kg/m2
- For female participants: regular menstrual cycles, no significant discomfort during pre-menses/menses
- Daily sleep duration between 7.0-9.0 hours, verified by sleep log/actigraphy data for two weeks
- Habitual sleep period must begin within one hour of 2300h (to ensure normal entrainment)
- Blood chemistry in the normal range
Who cannot join
- Active infection/disease.
- History of psychiatric, neurological, pain-related, immune, gastrointestinal, or cardiovascular disease; significant allergy; Raynaud's syndrome.
- History of intolerance or allergy to non-steroidal anti-inflammatory drugs (NSAID)
- Esophageal reflux; gastric or duodenal ulcers; or asthma
- Pregnant/nursing.
- Respiratory disturbance index of >5 events/hour on polysomnographic sleep study, periodic leg movement index (PLMI) >15/hour; sleep efficiency <80% (findings indicative of a sleep disorder).
Show all 9Show fewer
- Regular medication use other than oral contraceptives.
- Donation of blood or platelets 3 month prior to or in-between in-hospital visits.
- Substance abuse.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
The main purpose of this study is to learn about the effects of sleep disruption (two days in a row where sleep is shortened and disrupted) on inflammation, mood (how you feel), and pain processing (your own experiences/perceptions of pain). In this research project, we are trying to figure out if we can change the effects of sleep disruption on inflammation, mood, and pain. Therefore, we will study whether taking a low-dose aspirin pill every day over 2 weeks can change how we respond to sleep disruption. For example, does the sensitivity to pain (e.g., how intense the feeling of pain is if we put our hand in very hot or very cold water) change with sleep disruption, and can low-dose aspirin influence this change. We are also interested in seeing how inflammation changes in relation to your own perceived experience of pain.
Read the detailed description
Sleep that is deficient in quantity or quality leads to upregulation of inflammatory markers (Mullington et al., 2010). In particular, interleukin (IL)-6 and prostaglandin (PG) E2 are elevated in experimental models of sleep restriction or total sleep deprivation, as well as in insomnia. Inflammation is thought to be a key mechanism through which insufficient sleep increases the risk of developing or exacerbating various disorders, including cardiovascular and metabolic disorders (Mullington et al., 2009), as well as pain-related disorders (Haack et al., 2009c). With respect to pain, markers such as IL-6 and PGE2 are able to sensitize pain transmission neurons, thereby increasing their responsiveness to stimulation. In the context of insufficient sleep, both IL-6 and PGE2 have been shown to be associated with increased spontaneous pain (Haack et al., 2007;Haack et al., 2009a), suggesting their mediating role in pain amplification as a consequence of insufficient sleep.
These findings raise the question of whether pain amplification can be dampened by preventing the inflammatory increase in response to insufficient sleep.
The primary goal of this pilot project is to gather preliminary support for the hypothesis that deficient sleep leads to pain amplification through an inflammatory mechanism.
In addition to the primary goal of this proposal, the secondary goal is to gather preliminary data on the effects of aspirin on blood pressure regulation. Cardiovascular disease is the leading cause of death in the United States. A modest reduction of blood pressure (BP; i.e., 3 to 5 mmHg) in the population will produce a significant fall in serious cardiovascular events (Turnbull, 2003). It has been reported that low-dose aspirin may significantly reduce BP (i.e., 6 to 7 mmHg) when taken at bedtime (Hermida et al., 1994;Hermida et al., 1997;Hermida et al., 2003b;Hermida et al., 2003a;Hermida et al., 2005a;Hermida et al., 2005b). Aspirin, when taken at bedtime, may modulate 24h blood pressure by decreasing the nocturnal rise of renin-angiotensin-aldosterone system (RAAS) activity (Snoep et al., 2009) and attenuating the nocturnal drop in nitric oxide (NO) production (Hermida et al., 2005b). However, the underlying mechanisms are still unknown. Therefore, the second goal of this pilot project is to investigate the potential mechanisms contributing to BP reduction in response to aspirin taken at bedtime.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Also called non-steroidal anti-inflammatory drug
81mg aspirin daily at bedtime over a 2 week period
PlaceboDrug
pill that looks like aspirin without the effects of aspirin
| Study group | Role | What they receive |
|---|---|---|
| Insomnia symptom induction/placebo | Placebo comparator | Daily intake of pill at bedtime over 2-week period prior to and during the 5-day in-hospital stay Receives: Drug: Placebo |
| Insomnia symptom induction/aspirin | Experimental | Daily intake of pill at bedtime over 2-week period prior to and during the 5-day in-hospital stay Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammation
interleukin 6
Measured: Measured in plasma and urine 3 times/day over the 5-day in-hospital stay (after 2 weeks of pill admin)
Secondary outcomes (1)
Pain sensitivity
Thermode will be attached to the skin and participant has to rate the intensity of the heat or cold sensation via visual analog scales
Measured: Measured once per day during in-hospital days 1-5 (after 2 weeks of pill admin)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionOct 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 InsomniaStudies 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 8 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
- NCT02268565
- Sponsor's protocol ID
- 2014P000269
- Status last verified
- Mar 2017
- First submitted
- 23 Sep 2014
- Last updated
- 15 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing the Inflammatory Response to Experimentally-induced Insomnia Symptoms
- ClinicalTrials.gov ID
- NCT02268565
- Acronym / sponsor ID
- 2014P000269
- Conditions
- Insomnia
- Keywords
- sleep, insomnia, inflammation, pain, Insomnia symptom induction/placebo, Insomnia symptom induction/aspirin
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 20 Oct 2014 (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 sleep disruption (two days in a row where sleep is shortened and disrupted) on inflammation, mood (how you feel), and pain processing (your own experiences/perceptions of pain). In this research project, we are trying to figure out if we can change the effects of sleep disruption on inflammation, mood, and pain. Therefore, we will study whether taking a low-dose aspirin pill every day over 2 weeks can change how we respond to sleep disruption. For example, does the sensitivity to pain (e.g., how intense the feeling of pain is if we put our hand in very hot or very cold water) change with sleep disruption, and can low-dose aspirin influence this change. We are also interested in seeing how inflammation changes in relation to your own perceived experience of pain.
Detailed description
Sleep that is deficient in quantity or quality leads to upregulation of inflammatory markers (Mullington et al., 2010). In particular, interleukin (IL)-6 and prostaglandin (PG) E2 are elevated in experimental models of sleep restriction or total sleep deprivation, as well as in insomnia. Inflammation is thought to be a key mechanism through which insufficient sleep increases the risk of developing or exacerbating various disorders, including cardiovascular and metabolic disorders (Mullington et al., 2009), as well as pain-related disorders (Haack et al., 2009c). With respect to pain, markers such as IL-6 and PGE2 are able to sensitize pain transmission neurons, thereby increasing their responsiveness to stimulation. In the context of insufficient sleep, both IL-6 and PGE2 have been shown to be associated with increased spontaneous pain (Haack et al., 2007;Haack et al., 2009a), suggesting their mediating role in pain amplification as a consequence of insufficient sleep.
These findings raise the question of whether pain amplification can be dampened by preventing the inflammatory increase in response to insufficient sleep.
The primary goal of this pilot project is to gather preliminary support for the hypothesis that deficient sleep leads to pain amplification through an inflammatory mechanism.
In addition to the primary goal of this proposal, the secondary goal is to gather preliminary data on the effects of aspirin on blood pressure regulation. Cardiovascular disease is the leading cause of death in the United States. A modest reduction of blood pressure (BP; i.e., 3 to 5 mmHg) in the population will produce a significant fall in serious cardiovascular events (Turnbull, 2003). It has been reported that low-dose aspirin may significantly reduce BP (i.e., 6 to 7 mmHg) when taken at bedtime (Hermida et al., 1994;Hermida et al., 1997;Hermida et al., 2003b;Hermida et al., 2003a;Hermida et al., 2005a;Hermida et al., 2005b). Aspirin, when taken at bedtime, may modulate 24h blood pressure by decreasing the nocturnal rise of renin-angiotensin-aldosterone system (RAAS) activity (Snoep et al., 2009) and attenuating the nocturnal drop in nitric oxide (NO) production (Hermida et al., 2005b). However, the underlying mechanisms are still unknown. Therefore, the second goal of this pilot project is to investigate the potential mechanisms contributing to BP reduction in response to aspirin taken at bedtime.
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 |
|---|---|---|
| Insomnia symptom induction/placebo | Placebo comparator | Drug: PlaceboDaily intake of pill at bedtime over 2-week period prior to and during the 5-day in-hospital stay |
| Insomnia symptom induction/aspirin | Experimental | Drug: AspirinDaily intake of pill at bedtime over 2-week period prior to and during the 5-day in-hospital stay |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women and men between the ages 18-35 years
- Body mass index (BMI) between 18.5 and 30.0 kg/m2
- For female participants: regular menstrual cycles, no significant discomfort during pre-menses/menses
- Daily sleep duration between 7.0-9.0 hours, verified by sleep log/actigraphy data for two weeks
- Habitual sleep period must begin within one hour of 2300h (to ensure normal entrainment)
Key exclusion criteria (9 listed)
- Active infection/disease.
- History of psychiatric, neurological, pain-related, immune, gastrointestinal, or cardiovascular disease; significant allergy; Raynaud's syndrome.
- History of intolerance or allergy to non-steroidal anti-inflammatory drugs (NSAID)
- Esophageal reflux; gastric or duodenal ulcers; or asthma
- 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 |
|---|---|---|
| AspirinAlso: non-steroidal anti-inflammatory drug81mg aspirin daily at bedtime over a 2 week period | Drug | Insomnia symptom induction/aspirin |
| Placebopill that looks like aspirin without the effects of aspirin | Drug | Insomnia symptom induction/placebo |
Primary outcome
Inflammation
Time frame: Measured in plasma and urine 3 times/day over the 5-day in-hospital stay (after 2 weeks of pill admin)
interleukin 6
1 secondary outcome
Pain sensitivity
Time frame: Measured once per day during in-hospital days 1-5 (after 2 weeks of pill admin)
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 Mar 2017.
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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 Early Phase 1 study testing Aspirin in people with Insomnia, 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 6 inclusion and 9 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 Mar 2017. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Inflammation (time frame: Measured in plasma and urine 3 times/day over the 5-day in-hospital stay (after 2 weeks of pill admin)). 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 Mar 2017.