Trial Outcomes & Findings for Metabolomics of Insomnia-Related Hyperarousal (NCT NCT01957111)
NCT ID: NCT01957111
Last Updated: 2017-01-11
Results Overview
Metabolomics analysis of blood samples were carried out using Spectroscopy. This approach allows for rapid, unbiased and quantitative metabolic profiles ('fingerprints) to be acquired. A total of 70 metabolites were measured and compared between individuals with insomnia and good sleepers.
Recruitment status
COMPLETED
Target enrollment
32 participants
Primary outcome timeframe
48 hours
Results posted on
2017-01-11
Participant Flow
Participants were recruited from the general community and consisted of a group of with chronic insomnia disorder and age- and sex-matched good sleepers.
Participant milestones
| Measure |
Individuals With Insomnia
Participants with insomnia met the following Research Diagnostic Criteria for primary insomnia: subjective complaint of difficulty initiating or maintaining sleep, waking up too early or nonrestorative sleep, daytime consequences as a result of the poor sleep, duration of at least 1 month, sleep disturbance is not secondary to a medical or psychiatric condition based or the effects of a substance, as determined by clinical history. In order to exclude individuals with mild insomnia, insomnia had to occur on 3 or more nights per week for three months or longer. A 30-minute criterion was used such that subjects had to report taking 30 minutes or longer to fall asleep and/or spend 30 minutes awake during the night.
|
Good Sleepers
To be considered a good sleeper, participants had to report that they did not have difficulty falling asleep or staying asleep. A 15-minute criterion was used such that subjects had to report taking 15 minutes or less to fall asleep and spend 15 minutes or less awake during the night.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Individuals With Insomnia
Participants with insomnia met the following Research Diagnostic Criteria for primary insomnia: subjective complaint of difficulty initiating or maintaining sleep, waking up too early or nonrestorative sleep, daytime consequences as a result of the poor sleep, duration of at least 1 month, sleep disturbance is not secondary to a medical or psychiatric condition based or the effects of a substance, as determined by clinical history. In order to exclude individuals with mild insomnia, insomnia had to occur on 3 or more nights per week for three months or longer. A 30-minute criterion was used such that subjects had to report taking 30 minutes or longer to fall asleep and/or spend 30 minutes awake during the night.
|
Good Sleepers
To be considered a good sleeper, participants had to report that they did not have difficulty falling asleep or staying asleep. A 15-minute criterion was used such that subjects had to report taking 15 minutes or less to fall asleep and spend 15 minutes or less awake during the night.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Metabolomics of Insomnia-Related Hyperarousal
Baseline characteristics by cohort
| Measure |
Individuals With Insomnia
n=15 Participants
Participants with insomnia met the following Research Diagnostic Criteria for primary insomnia: subjective complaint of difficulty initiating or maintaining sleep, waking up too early or nonrestorative sleep, daytime consequences as a result of the poor sleep, duration of at least 1 month, sleep disturbance is not secondary to a medical or psychiatric condition based or the effects of a substance, as determined by clinical history. In order to exclude individuals with mild insomnia, insomnia had to occur on 3 or more nights per week for three months or longer. A 30-minute criterion was used such that subjects had to report taking 30 minutes or longer to fall asleep and/or spend 30 minutes awake during the night.
|
Good Sleepers
n=15 Participants
To be considered a good sleeper, participants had to report that they did not have difficulty falling asleep or staying asleep. A 15-minute criterion was used such that subjects had to report taking 15 minutes or less to fall asleep and spend 15 minutes or less awake during the night.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.0 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
36.0 years
STANDARD_DEVIATION 7.5 • n=7 Participants
|
36.5 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
Gender
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Gender
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 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
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 48 hoursMetabolomics analysis of blood samples were carried out using Spectroscopy. This approach allows for rapid, unbiased and quantitative metabolic profiles ('fingerprints) to be acquired. A total of 70 metabolites were measured and compared between individuals with insomnia and good sleepers.
Outcome measures
| Measure |
Individuals With Insomnia
n=15 Participants
Participants with insomnia met the following Research Diagnostic Criteria for primary insomnia: subjective complaint of difficulty initiating or maintaining sleep, waking up too early or nonrestorative sleep, daytime consequences as a result of the poor sleep, duration of at least 1 month, sleep disturbance is not secondary to a medical or psychiatric condition based or the effects of a substance, as determined by clinical history. In order to exclude individuals with mild insomnia, insomnia had to occur on 3 or more nights per week for three months or longer. A 30-minute criterion was used such that subjects had to report taking 30 minutes or longer to fall asleep and/or spend 30 minutes awake during the night.
|
Good Sleepers
n=15 Participants
To be considered a good sleeper, participants had to report that they did not have difficulty falling asleep or staying asleep. A 15-minute criterion was used such that subjects had to report taking 15 minutes or less to fall asleep and spend 15 minutes or less awake during the night.
|
|---|---|---|
|
Number of Metabolites Elevated Relative to the Other Group.
|
13 Number of metabolites elevated
|
9 Number of metabolites elevated
|
SECONDARY outcome
Timeframe: 1 nightParticipants will have their sleep measured with polysomnography for one night. The sleep of individuals with insomnia will be compared to that of good sleepers. Sleep quality is defined as sleep efficiency, which is calculated at total sleep time / total time spent in bed x 100. It indicates the % of time spent asleep while in bed.
Outcome measures
| Measure |
Individuals With Insomnia
n=15 Participants
Participants with insomnia met the following Research Diagnostic Criteria for primary insomnia: subjective complaint of difficulty initiating or maintaining sleep, waking up too early or nonrestorative sleep, daytime consequences as a result of the poor sleep, duration of at least 1 month, sleep disturbance is not secondary to a medical or psychiatric condition based or the effects of a substance, as determined by clinical history. In order to exclude individuals with mild insomnia, insomnia had to occur on 3 or more nights per week for three months or longer. A 30-minute criterion was used such that subjects had to report taking 30 minutes or longer to fall asleep and/or spend 30 minutes awake during the night.
|
Good Sleepers
n=15 Participants
To be considered a good sleeper, participants had to report that they did not have difficulty falling asleep or staying asleep. A 15-minute criterion was used such that subjects had to report taking 15 minutes or less to fall asleep and spend 15 minutes or less awake during the night.
|
|---|---|---|
|
Sleep Efficiency Percentage on Overnight Sleep Study
|
75.8 % sleep efficiency
Standard Deviation 14.6
|
80.7 % sleep efficiency
Standard Deviation 9.8
|
Adverse Events
Individuals With Insomnia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Good Sleepers
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place