Trial Outcomes & Findings for Challenging the Inflammatory Response System in Insomnia Disorder (NCT NCT02261597)
NCT ID: NCT02261597
Last Updated: 2019-07-22
Results Overview
Inflammatory marker: Change in plasma levels of IL-6 (pg/mL).
Recruitment status
COMPLETED
Target enrollment
44 participants
Primary outcome timeframe
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.
Results posted on
2019-07-22
Participant Flow
Participant milestones
| Measure |
Healthy Controls
Healthy participants without a diagnosis of insomnia disorder visited the CRC for a one-day stay immediately following an overnight sleep screen
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
|
Overall Study
COMPLETED
|
22
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Challenging the Inflammatory Response System in Insomnia Disorder
Baseline characteristics by cohort
| Measure |
Healthy Controls
n=22 Participants
Healthy participants without a diagnosis of insomnia disorder visited the CRC for a one-day stay immediately following an overnight sleep screen.
|
Insomnia Disorder
n=22 Participants
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.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
26.09 years
n=5 Participants
|
30.27 years
n=7 Participants
|
28.18 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
22 participants
n=7 Participants
|
44 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.Population: Data of 3 participants were excluded from analysis due to development of headache or Iv problems in the course of the experimental study day.
Inflammatory marker: Change in plasma levels of IL-6 (pg/mL).
Outcome measures
| Measure |
Healthy Controls
n=21 Participants
Healthy participants without a diagnosis of insomnia disorder visited the CRC for a one-day stay immediately following an overnight sleep screen
|
Insomnia Disorder
n=20 Participants
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
|
|---|---|---|
|
Inflammatory Response to Physiological Challenge- Change in Plasma Levels of IL-6
Baseline
|
1.5013 pg/mL
Standard Error 0.16892
|
2.1626 pg/mL
Standard Error 0.67566
|
|
Inflammatory Response to Physiological Challenge- Change in Plasma Levels of IL-6
20min after CPT 1
|
2.5911 pg/mL
Standard Error 0.49528
|
2.7269 pg/mL
Standard Error 0.5303
|
|
Inflammatory Response to Physiological Challenge- Change in Plasma Levels of IL-6
50 min after CPT 1
|
3.0318 pg/mL
Standard Error 0.55967
|
2.7556 pg/mL
Standard Error 0.31272
|
|
Inflammatory Response to Physiological Challenge- Change in Plasma Levels of IL-6
20 min after CPT 2
|
3.7131 pg/mL
Standard Error 0.65019
|
3.8603 pg/mL
Standard Error 0.53619
|
|
Inflammatory Response to Physiological Challenge- Change in Plasma Levels of IL-6
50 min after CPT 2
|
4.2044 pg/mL
Standard Error 0.64394
|
3.3381 pg/mL
Standard Error 0.4539
|
|
Inflammatory Response to Physiological Challenge- Change in Plasma Levels of IL-6
20 min after CPT 3
|
5.514 pg/mL
Standard Error 0.82173
|
5.1606 pg/mL
Standard Error 0.95047
|
|
Inflammatory Response to Physiological Challenge- Change in Plasma Levels of IL-6
50 min after CPT 3
|
5.9841 pg/mL
Standard Error 1.15086
|
4.3278 pg/mL
Standard Error 0.75218
|
PRIMARY outcome
Timeframe: 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.Population: Data of 3 participants were excluded from analysis due to development of headache or Iv problems in the course of the experimental study day.
HPA marker: Change in serum cortisol levels (ug/dL)
Outcome measures
| Measure |
Healthy Controls
n=21 Participants
Healthy participants without a diagnosis of insomnia disorder visited the CRC for a one-day stay immediately following an overnight sleep screen
|
Insomnia Disorder
n=20 Participants
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
|
|---|---|---|
|
Stress Reactivity to Physiological Challenge- Change in Serum Levels of Cortisol
Baseline
|
8.9948 ug/dL
Standard Error 1.00453
|
9.8250 ug/dL
Standard Error 0.92339
|
|
Stress Reactivity to Physiological Challenge- Change in Serum Levels of Cortisol
20min after CPT 1
|
10.6695 ug/dL
Standard Error 0.61099
|
13.95 ug/dL
Standard Error 1.22551
|
|
Stress Reactivity to Physiological Challenge- Change in Serum Levels of Cortisol
50 min after CPT 1
|
8.3255 ug/dL
Standard Error 0.47898
|
11.0416 ug/dL
Standard Error 0.95435
|
|
Stress Reactivity to Physiological Challenge- Change in Serum Levels of Cortisol
20 min after CPT 2
|
8.448 ug/dL
Standard Error 0.57976
|
10.9342 ug/dL
Standard Error 1.13843
|
|
Stress Reactivity to Physiological Challenge- Change in Serum Levels of Cortisol
50 min after CPT 2
|
6.452 ug/dL
Standard Error 0.39262
|
8.6063 ug/dL
Standard Error 0.98503
|
|
Stress Reactivity to Physiological Challenge- Change in Serum Levels of Cortisol
20 min after CPT 3
|
8.7545 ug/dL
Standard Error 0.71965
|
9.9168 ug/dL
Standard Error 1.27366
|
|
Stress Reactivity to Physiological Challenge- Change in Serum Levels of Cortisol
50 min after CPT 3
|
6.651 ug/dL
Standard Error 0.40265
|
8.4684 ug/dL
Standard Error 1.01139
|
SECONDARY outcome
Timeframe: Monocytes are only obtained from the baseline blood draw, which occurs at 11am.Population: Data of 2 participants were excluded from analysis due to development of headache or Iv problems in the course of the experimental study day.
Percentage of IL-6 positive monocytes following stimulation with LPS (100pg/mL) and varying concentrations of Dexamethasone
Outcome measures
| Measure |
Healthy Controls
n=22 Participants
Healthy participants without a diagnosis of insomnia disorder visited the CRC for a one-day stay immediately following an overnight sleep screen
|
Insomnia Disorder
n=20 Participants
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
|
|---|---|---|
|
Glucocorticoid Sensitivity- Percentage of IL-6 Positive Monocytes
|
20.659 Percentage of IL-6 positive monocytes
Standard Error 2.9058
|
17.250 Percentage of IL-6 positive monocytes
Standard Error 1.9317
|
Adverse Events
Healthy Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Insomnia Disorder
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Monika Haack
Beth Israel Deaconess Medical Center, Harvard Medical School
Phone: 617-667-5234
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place