Status:
COMPLETED
Preventing the Inflammatory Response to Experimentally-induced Insomnia Symptoms
Lead Sponsor:
Beth Israel Deaconess Medical Center
Conditions:
Insomnia
Eligibility:
All Genders
18-35 years
Phase:
EARLY_PHASE1
Brief 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 (y...
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 expe...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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).
- Regular medication use other than oral contraceptives.
- Donation of blood or platelets 3 month prior to or in-between in-hospital visits.
- Substance abuse.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT02268565
Start Date
October 1 2014
End Date
December 1 2016
Last Update
March 15 2017
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215