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Inflammatory ResponseEarly Phase 1NCT03377543

Sleep and Inflammatory Resolution Pathway

A Early Phase 1 study testing Aspirin in people with Inflammatory Response and Inflammation, run by Beth Israel Deaconess Medical Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Goal of this project is to investigate whether increases in inflammation that result from common patterns of restricting sleep on week nights and catching up on sleep over the weekend are caused by disruption in the newly discovered inflammatory resolution pathways. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Inflammatory Response, Inflammation, Sleep
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
66 participants
Where
1 siteUnited States
Study dates
6 Jun 2018to 30 Jun 2027
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Women and men between the ages 18-65 years.
  • Body mass index (BMI) between 18.5 and 35 kg/m2.
  • For female participants: No significant discomfort during pre-menses/menses.
  • Daily sleep duration between 7-9 hours, verified by electronic sleep diary data for two weeks.
  • Habitual sleep period must begin within one hour of 11:00pm (to ensure normal entrainment).
  • Negative toxicology screen, including: amphetamines, barbiturates, benzodiazepines, cocaine, opiates, and methadone. Toxicology screening will be performed as part of the screening lab tests; an outside lab toxicology screening will not suffice.

Who cannot join

  • Active infection/disease.
  • Following blood chemistry values outside of the laboratory's normal range or the range specified below:
  • WBC (range: 2.0-10.0 K/uL)
  • Platelet count
  • Hematocrit in range
  • TSH outside of the laboratory's normal range
Show all 24Show fewer
  • Bilirubin >1.5 upper limit of normal
  • ALT or AST >2.5 upper limit of normal
  • Stage 4 chronic kidney disease based on CKD epi-equation
  • Pre-diabetes or diabetes (HbA1c >5.7%)
  • History of neurological, chronic pain, immune/inflammatory, vascular/cardiovascular (including Raynaud syndrome), liver/kidney, metabolic disorders (including diabetes).
  • Current asthma (diagnosis of asthma and either asthma symptoms present within the past years or taking medication for asthma) and/or history of ASA induced sensitivity
  • Systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90 mmHg prior to the initial and medical screens. Systolic blood pressure ≥ 160mmHg and/or diastolic blood pressure ≥ 100mmHg during admissions (Stays 1, 2, and 3)
  • History of gastrointestinal disorders, including esophageal reflux, gastric and duodenal ulcers, gastrointestinal bleeding.
  • Personal or family (first degree relative) history of any stroke
  • History of psychiatric disorders, including major depressive disorders, bipolar disorders, panic disorders, post-traumatic stress disorders (PTSD), thought disorders, and substance abuse/dependence disorders.
  • History of intolerance or allergy to non-steroidal anti-inflammatory drugs (NSAID).
  • Sleep disorders: Sleep efficiency <80% based on polysomnographic (PSG) screening night; respiratory disturbance index of >10 events/hour based on PSG screening night, periodic leg movement index (PLMI) of >25/hour and/or PLMAI (PLM arousal index) of >5/hour based on PSG screening night; restless legs syndrome, circadian rhythm disorders, and nightmare disorders determined by diagnostic interview.
  • Pregnant/nursing.
  • Regular medication use other than oral contraceptives.
  • Intake of non-steroidal anti-inflammatory drugs (NSAIDs) or cold/cough remedies within the last month.
  • Intake of dietary supplements containing DHA/EPA-derived fatty acids (e.g., fish oil) within the last 3 months prior to study start.
  • Donation of blood or platelets within three months prior to or in-between study arms.
  • Smoking.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: Patterns of Sleep Restriction and Recovery: The Inflammatory Resolution Pathways

Goal of this project is to investigate whether increases in inflammation that result from common patterns of restricting sleep on week nights and catching up on sleep over the weekend are caused by disruption in the newly discovered inflammatory resolution pathways. These pathways are crucial in the active termination of the inflammatory response, and their disruption may contribute to ongoing unresolved inflammation, which has been observed not only during periods of sleep restriction, but also after recovery sleep has been obtained. If the hypothesis is true, it is possible that increasing the body's natural production of endogenous, inflammatory resolution mediators may provide a non-behavioral strategy to limit the inflammatory consequences in those undergoing periods of sleep restriction with intermittent recovery sleep.

Read the detailed description

Low-grade or unresolved inflammation is involved in the pathogenesis of many human diseases. Common sleep patterns of restricting sleep during the work week and "catching up" on sleep over the weekend lead to inflammatory upregulation that does not recover completely after the weekend.

The goal of this proposal is to investigate, for the first time, inflammatory resolution pathways. Inflammatory resolution mediators, such as resolvins, are derived from omega-3 free fatty acids and actively 'turn-off' inflammation. Based on preliminary data, the investigators hypothesize that common sleep restriction-recovery patterns disrupt inflammatory resolution pathways, making it difficult to return to inflammatory homeostasis. If true, pharmacologically increasing the body's natural production of endogenous inflammatory resolution mediators may provide a way to reduce the detrimental inflammatory consequences of common sleep restriction-recovery patterns.

The hypothesis will be tested using an experimental model that mimics common patterns of restricting sleep on weekdays and "catching up" on sleep on the weekend. The proposal will further utilize the unique ability of low-dose aspirin, which - like no other non-steroidal anti-inflammatory drug - is able to activate inflammatory resolution pathways. Healthy women and men between the ages of 18 to 65 years will be tested under three, 11-day in-hospital stays, during which participants will be exposed to control sleep or common patterns of sleep restriction-recovery. The three in-hospital stays will be combined with preemptive administration of low-dose aspirin or a placebo.

Targeting inflammatory resolution pathways could provide a novel, non-behavioral strategy to mitigate both inflammatory consequences and future disease risks in those undergoing periods of sleep restriction-recovery patterns - a behavior pattern that is unlikely to be eradicated in the near future, as changes in sleep are generally difficult to make and to maintain.

Being tested
Aspirin, Placebo
Medical subject headings
Inflammation

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 pill daily at bedtime over a 25 day period

  • PlaceboDrug

    81mg non-active pill that looks like aspirin

Study groups in NCT03377543
Study groupRoleWhat they receive
Control Sleep/Non-Active Placebo or 81mg Aspirin PillExperimentalDaily intake of pill at bedtime over 2-week period prior to and during the 11-day in-hospital stay
Receives: Drug: Aspirin; Drug: Placebo
Sleep Restriction/81mg Aspirin PillExperimentalDaily intake of pill at bedtime over 2-week period prior to and during the 11-day in-hospital stay
Receives: Drug: Aspirin
Sleep Restriction/Non-Active PlaceboExperimentalDaily intake of pill at bedtime over 2-week period prior to and during the 11-day in-hospital stay
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Inflammatory Resolution Markers

    Resolvins

    Measured: Change from baseline to sleep restriction, single measure in the morning

Secondary outcomes (1)

  1. Inflammatory Markers

    Interleukin-6

    Measured: Change from baseline to sleep restriction, single measure in the morning

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2017
  2. Study start6 Jun 2018
  3. Primary completion30 Dec 2025
  4. Study completion30 Jun 2027 (estimated)

Resources

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
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03377543
Sponsor's protocol ID
2017P000484
Status last verified
Oct 2026
First submitted
4 Dec 2017
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Nett S, Dang R, Engert LC, Daniel S, Wang J, Albrecht S, Taj M, Sethna N, Haack M. Effects of Low-Dose Acetylsalicylic Acid on Spontaneous Pain, Pain Sensitivity, and Central Pain Modulation in Response to a Sleep Restriction Challenge in Healthy Individuals. Eur J Pain. 2026 Oct;30(9):e70392. doi: 10.1002/ejp.70392.

    PubMed 42781832

  • Sun H, Dang R, Li P, Xiao W, Scott-Sutherland J, Sassower KC, Westover MB, Felsenstein D, Thomas RJ, Haack M, Mullington JM. Facility-measured sleep electroencephalographic microstructures in long COVID. Sleep. 2026 Aug 14;49(8):zsag090. doi: 10.1093/sleep/zsag090.

    PubMed 42017829

  • Engert LC, Dang R, Chatterton B, Daniel S, Mullington JM, Haack M. The Effect of Low-Dose Acetylsalicylic Acid on Cellular Immune Responses to Experimental Sleep Restriction in Healthy Humans. Neuroimmunomodulation. 2026;33(1):125-137. doi: 10.1159/000551037. Epub 2026 Feb 13.

    PubMed 41686719

  • Engert LC, Ledderose C, Biniamin C, Birriel P, Buraks O, Chatterton B, Dang R, Daniel S, Eske A, Reed T, Tang A, Bertisch SM, Mullington JM, Junger WG, Haack M. Effects of low-dose acetylsalicylic acid on the inflammatory response to experimental sleep restriction in healthy humans. Brain Behav Immun. 2024 Oct;121:142-154. doi: 10.1016/j.bbi.2024.07.023. Epub 2024 Jul 21.

    PubMed 39043348

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Aspirin in people with Inflammatory Response and Inflammation, 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 24 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: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. 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?

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?

This study is still under way. Results are not available in the source record yet.

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 Resolution Markers (time frame: Change from baseline to sleep restriction, single measure in the morning). 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 NCT03377543, which also lists 4 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 26 Oct 2026.

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