Sleep and Inflammatory Resolution Pathway

• Status: Recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Beth Israel Deaconess Medical Center
• Treatments: Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Aspirin

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

• 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.