InsomniaNCT02261597
Challenging the Inflammatory Response System in Insomnia Disorder
An observational study of Insomnia, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia
- What is being tested?
- Cold Pressor Test
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Mar 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: * Individuals suffering from insomnia disorder * Healthy control sleepers
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Challenging the Inflammatory Response System: Are Individuals With Insomnia More Reactive?
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.
Read the 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, 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.
- Conditions
- Insomnia
- Being tested
- Cold Pressor Test
- Keywords
- insomnia, inflammation, stress
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold Pressor TestBehavioural
Repeated immersion of hand in ice-cold water
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Cold Pressor Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory Response to Physiological Challenge- Change in Plasma Levels of IL-6
Inflammatory marker: Change in plasma levels of IL-6 (pg/mL).
Measured: 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)
Measured: 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
Percentage of IL-6 positive monocytes following stimulation with LPS (100pg/mL) and varying concentrations of Dexamethasone
Measured: Monocytes are only obtained from the baseline blood draw, which occurs at 11am.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2014 (estimated)
- Study startJan 2015
- Primary completionJun 2017
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monika Haack, Beth Israel Deaconess Medical Center
- Investigators
- Haack Monika, PhD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02261597
- Sponsor's protocol ID
- 2014P000297
- Status last verified
- Jul 2019
- First submitted
- 7 Oct 2014
- Last updated
- 22 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Challenging the Inflammatory Response System: Are Individuals With Insomnia More Reactive?
- ClinicalTrials.gov ID
- NCT02261597
- Acronym / sponsor ID
- 2014P000297
- Conditions
- Insomnia
- Keywords
- insomnia, inflammation, stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jun 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 10 Oct 2014 (estimated)
- Results
- Posted 17 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insomnia Disorder | – | Behavioral: Cold Pressor TestTesting 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 | – | Behavioral: Cold Pressor TestTesting 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- * Individuals suffering from insomnia disorder * Healthy control sleepers
Key inclusion criteria (7 listed)
- Women and men between the ages 18-55 years
- Blood chemistry in the normal range
- BMI less than or equal to 35
- Diagnosis of insomnia disorder based on DSM-V criteria
- Good quality and quantity sleep
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold Pressor TestRepeated immersion of hand in ice-cold water | Behavioural | Healthy Control, Insomnia Disorder |
Primary outcome
Inflammatory Response to Physiological Challenge- Change in Plasma Levels of IL-6
Time frame: 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.
Inflammatory marker: Change in plasma levels of IL-6 (pg/mL).
Stress Reactivity to Physiological Challenge- Change in Serum Levels of Cortisol
Time frame: 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.
HPA marker: Change in serum cortisol levels (ug/dL)
1 secondary outcome
Glucocorticoid Sensitivity- Percentage of IL-6 Positive Monocytes
Time frame: Monocytes are only obtained from the baseline blood draw, which occurs at 11am.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haack Monika, PhD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insomnia, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory Response to Physiological Challenge- Change in Plasma Levels of IL-6 (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2019.