Preventing the Inflammatory Response to Experimentally-induced Insomnia Symptoms

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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 (your own experiences/perceptions of pain). In this research project, we are trying to figure out if we can change the effects of sleep disruption on inflammation, mood, and pain. Therefore, we will study whether taking a low-dose aspirin pill every day over 2 weeks can change how we respond to sleep disruption. For example, does the sensitivity to pain (e.g., how intense the feeling of pain is if we put our hand in very hot or very cold water) change with sleep disruption, and can low-dose aspirin influence this change. We are also interested in seeing how inflammation changes in relation to your own perceived experience of pain.

• 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 18-35 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 Criteria:

• 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.