Challenging the Inflammatory Response System in Insomnia Disorder

NCT02261597 | Completed Results

• 1 other identifier: 2014P000297
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

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 water for several times in a row. In particular, the investigators are interested in the response of markers that can be associated with stress, such as blood pressure and stress hormones.

Conditions

Insomnia

Keywords

insomnia, inflammation, stress

Outcome Measures

Primary Outcomes (2)

• Inflammatory Response to Physiological Challenge- Change in Plasma Levels of IL-6

  Inflammatory marker: Change in plasma levels of IL-6 (pg/mL).

  Baseline blood was obtained between 11am-12pm and prior to any Cold Pressor Tests (CPTs). Three CPTs were performed, with 1.5 hours between each one. The first CPT was done at 1pm. Blood draws were obtained 20min and 50 min after each CPT.

• Stress Reactivity to Physiological Challenge- Change in Serum Levels of Cortisol

  HPA marker: Change in serum cortisol levels (ug/dL)

  Baseline blood was obtained between 11am-12pm and prior to any Cold Pressor Tests (CPTs). Three CPTs were performed, with 1.5 hours between each one. The first CPT was done at 1pm. Blood draws were obtained 20min and 50 min after each CPT.

Secondary Outcomes (1)

• Glucocorticoid Sensitivity- Percentage of IL-6 Positive Monocytes

  Monocytes are only obtained from the baseline blood draw, which occurs at 11am.

Study Arms (2)

Insomnia Disorder

Testing reactivity of stress-related systems to repeated exposure to the cold pressor test (hand immersion into ice-cold water) among participants with a clinical diagnosis of insomnia disorder.

Behavioral: Cold Pressor Test

Healthy Control

Testing reactivity of stress-related systems to repeated exposure to the cold pressor test (hand immersion into ice-cold water) among healthy participants without a diagnosis of insomnia disorder.

Behavioral: Cold Pressor Test

Interventions

Cold Pressor Test BEHAVIORAL

Repeated immersion of hand in ice-cold water

Healthy Control; Insomnia Disorder

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

* Individuals suffering from insomnia disorder * Healthy control sleepers

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

BIDMC

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Inflammation

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Monika Haack
• Organization: Beth Israel Deaconess Medical Center, Harvard Medical School

mhaack@bidmc.harvard.edu

617-667-5234

Study Officials

• Haack Monika, PhD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology HMS

Study Record Dates

• First Submitted: October 7, 2014
• First Posted: October 10, 2014
• Study Start: January 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: March 1, 2018
• Last Updated: July 22, 2019
• Results First Posted: June 17, 2019

Record last verified: 2019-07

Locations

US (1)