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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.
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, and mood disorders.
Despite the high prevalence of insomnia in the population, the investigators understanding of the biological consequences of the disorder with respect to inflammatory, autonomic, and stress system markers is limited, and often not consistent.
In addition, insomnia may not only alter the basal activity of these systems, but may change their reactivity to other stressors and challenges. In support of this assumption are findings showing that poor sleep quality in healthy individuals is associated with a stronger biological response to a stressful challenge, such as the cold pressor test. This test involves the immersion of the hand in ice-cold water. It is one of the most commonly used laboratory physiological challenge tests, provoking not only unpleasantness, but also increases in stress and inflammatory markers.
Investigations of such system's reactivity to challenge may elucidate systems abnormalities that the investigators do not capture by only assessing basal system's levels. For example, in patients with rheumatoid arthritis, basal inflammatory levels are normal, but the response to a physiological stress challenge (cold pressor test) is amplified.
To the investigators knowledge, no studies have measured how insomnia may affect the reactivity of biological systems to a stressful challenge, which may serve as an important indicator of system's dysregulation and associated disease risk.
In this light, the primary goal of this proposal will investigate whether stress-related systems are more reactive to a physiological stressful challenge in insomnia disorder compared to healthy controls.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cold Pressor Test | Behavioral | Repeated immersion of hand in ice-cold water |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Glucocorticoid Sensitivity- Percentage of IL-6 Positive Monocytes | Percentage of IL-6 positive monocytes following stimulation with LPS (100pg/mL) and varying concentrations of Dexamethasone | Monocytes are only obtained from the baseline blood draw, which occurs at 11am. |
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Inclusion Criteria:
Specific to insomnia group:
Specific for control group:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Haack Monika, PhD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BIDMC | Boston | Massachusetts | 02215 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Controls | Healthy participants without a diagnosis of insomnia disorder visited the CRC for a one-day stay immediately following an overnight sleep screen |
| FG001 | Insomnia Disorder | Participants with the diagnosis of insomnia disorder (according to DSM-V) visited the CRC for a one-day stay immediately following an overnight sleep screen |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Controls | Healthy participants without a diagnosis of insomnia disorder visited the CRC for a one-day stay immediately following an overnight sleep screen. |
| BG001 | Insomnia Disorder |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Inflammatory Response to Physiological Challenge- Change in Plasma Levels of IL-6 | Inflammatory marker: Change in plasma levels of IL-6 (pg/mL). | Data of 3 participants were excluded from analysis due to development of headache or Iv problems in the course of the experimental study day. | Posted | Mean | Standard Error | 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. |
|
Adverse event data were collected over a 9-hour period for each particpant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Controls | Healthy participants without a diagnosis of insomnia disorder visited the CRC for a one-day stay immediately following an overnight sleep screen |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Monika Haack | Beth Israel Deaconess Medical Center, Harvard Medical School | 617-667-5234 | mhaack@bidmc.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 26, 2016 | Apr 27, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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Participants with the diagnosis of insomnia disorder (according to DSM-V) visited the CRC for a one-day stay immediately following an overnight sleep screen.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Average age and age range for all participants in the study, and for each arm in the study | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Insomnia Disorder |
Participants with the diagnosis of insomnia disorder (according to DSM-V) visited the CRC for a one-day stay immediately following an overnight sleep screen |
|
|
| Primary | Stress Reactivity to Physiological Challenge- Change in Serum Levels of Cortisol | HPA marker: Change in serum cortisol levels (ug/dL) | Data of 3 participants were excluded from analysis due to development of headache or Iv problems in the course of the experimental study day. | Posted | Mean | Standard Error | 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 | Glucocorticoid Sensitivity- Percentage of IL-6 Positive Monocytes | Percentage of IL-6 positive monocytes following stimulation with LPS (100pg/mL) and varying concentrations of Dexamethasone | Data of 2 participants were excluded from analysis due to development of headache or Iv problems in the course of the experimental study day. | Posted | Mean | Standard Error | Percentage of IL-6 positive monocytes | Monocytes are only obtained from the baseline blood draw, which occurs at 11am. |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Insomnia Disorder | Participants with the diagnosis of insomnia disorder (DSM-V) visited the CRC for a one-day stay immediately following an overnight sleep screen. | 0 | 22 | 0 | 22 | 0 | 22 |
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| D001523 |
| Mental Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 20min after CPT 1 |
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| 50 min after CPT 1 |
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| 20 min after CPT 2 |
|
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| 50 min after CPT 2 |
|
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| 20 min after CPT 3 |
|
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| 50 min after CPT 3 |
|
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