Preventing the Inflammatory Response to Experimentally-induced Insomnia Symptoms

NCT02268565 | Completed Early Phase 1

• 1 other identifier: 2014P000269
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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 (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.

Conditions

Insomnia

Keywords

sleep, insomnia, inflammation, pain; Insomnia symptom induction/placebo; Insomnia symptom induction/aspirin

Outcome Measures

Primary Outcomes (1)

• Inflammation

  interleukin 6

  Measured in plasma and urine 3 times/day over the 5-day in-hospital stay (after 2 weeks of pill admin)

Secondary Outcomes (1)

• Pain sensitivity

  Measured once per day during in-hospital days 1-5 (after 2 weeks of pill admin)

Other Outcomes (1)

• Pain modulation

  Measured once per day during in-hospital days 1-5

Study Arms (2)

Insomnia symptom induction/placebo

PLACEBO COMPARATOR

Daily intake of pill at bedtime over 2-week period prior to and during the 5-day in-hospital stay

Drug: Placebo

Insomnia symptom induction/aspirin

EXPERIMENTAL

Daily intake of pill at bedtime over 2-week period prior to and during the 5-day in-hospital stay

Drug: Aspirin

Interventions

Aspirin DRUG

81mg aspirin daily at bedtime over a 2 week period

Also known as: non-steroidal anti-inflammatory drug

Insomnia symptom induction/aspirin

Placebo DRUG

pill that looks like aspirin without the effects of aspirin

Insomnia symptom induction/placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Inflammation; Pain

Interventions

Aspirin; Anti-Inflammatory Agents, Non-Steroidal

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents

Study Officials

• Monika Haack, PhD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology

Study Record Dates

• First Submitted: September 23, 2014
• First Posted: October 20, 2014
• Study Start: October 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 15, 2017

Record last verified: 2017-03

Locations

US (1)