Status:
COMPLETED
Challenging the Inflammatory Response System in Insomnia Disorder
Lead Sponsor:
Beth Israel Deaconess Medical Center
Conditions:
Insomnia
Eligibility:
All Genders
18-55 years
Brief Summary
The main purpose of this study is to understand how insomnia (compared to good sleep) may affect the response of the body to a repeated physiological challenge, such as inserting the hand in ice-cold ...
Detailed Description
Sleep is critical for the regulation and maintenance of biological systems, and sleep deficiency, such as insomnia, has been shown to be associated with elevated risks for cardiovascular, metabolic, a...
Eligibility Criteria
Inclusion
- Women and men between the ages 18-55 years
- Blood chemistry in the normal range
- BMI less than or equal to 35
- Specific to insomnia group:
- Diagnosis of insomnia disorder based on DSM-V criteria
- Specific for control group:
- Good quality and quantity sleep
Exclusion
- Active infection/disease.
- History of neurological, chronic pain, immune, cardiovascular, liver/kidney, or metabolic disorder
- History of psychiatric disorders within the last 6 months prior to study start
- Sleep disorders other than insomnia
- Reynaud's disease
- Psychotropic, sleep, or any other medications or herbs interfering with the inflammatory, autonomic, or HPA system in the last 2 weeks prior to study start, except oral contraceptives
- In psychotherapy or any other behavioral interventions at study start
- Donation of blood or platelets within 3 months of hospital visits
- Pregnant/nursing.
- Substance abuse.
Key Trial Info
Start Date :
January 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2018
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT02261597
Start Date
January 1 2015
End Date
March 1 2018
Last Update
July 22 2019
Active Locations (1)
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1
BIDMC
Boston, Massachusetts, United States, 02215