Sleep and Inflammatory Resolution Pathway
Patterns of Sleep Restriction and Recovery: the Inflammatory Resolution Pathways
1 other identifier
interventional
66
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Jun 2018
Longer than P75 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 4, 2017
CompletedFirst Posted
Study publicly available on registry
December 19, 2017
CompletedStudy Start
First participant enrolled
June 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2025
CompletedMarch 24, 2025
March 1, 2025
7.6 years
December 4, 2017
March 20, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Inflammatory Resolution Markers
Resolvins
Change from baseline to sleep restriction, single measure in the morning
Secondary Outcomes (1)
Inflammatory Markers
Change from baseline to sleep restriction, single measure in the morning
Study Arms (3)
Control Sleep/Non-Active Placebo or 81mg Aspirin Pill
EXPERIMENTALDaily intake of pill at bedtime over 2-week period prior to and during the 11-day in-hospital stay
Sleep Restriction/81mg Aspirin Pill
EXPERIMENTALDaily intake of pill at bedtime over 2-week period prior to and during the 11-day in-hospital stay
Sleep Restriction/Non-Active Placebo
EXPERIMENTALDaily intake of pill at bedtime over 2-week period prior to and during the 11-day in-hospital stay
Interventions
81mg aspirin pill daily at bedtime over a 25 day period
81mg non-active pill that looks like aspirin
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Related Publications (1)
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.
PMID: 39043348DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Monika Haack, PhD
Beth Israel Deaconess Medical Center
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Neurology
Study Record Dates
First Submitted
December 4, 2017
First Posted
December 19, 2017
Study Start
June 6, 2018
Primary Completion
December 30, 2025
Study Completion
December 30, 2025
Last Updated
March 24, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share