Status:
ACTIVE_NOT_RECRUITING
Sleep and Inflammatory Resolution Pathway
Lead Sponsor:
Beth Israel Deaconess Medical Center
Conditions:
Inflammatory Response
Inflammation
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
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 di...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT03377543
Start Date
June 6 2018
End Date
December 30 2025
Last Update
March 24 2025
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215