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Metabolomics of Insomnia-Related Hyperarousal

Metabolomics of Insomnia-Related Hyperarousal

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01957111
Enrollment
32
Registered
2013-10-08
Start date
2013-10-31
Completion date
2015-10-31
Last updated
2017-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Insomnia

Brief summary

Individuals with insomnia have been shown to have higher overall metabolic rates compared to good sleepers, but it is not known which metabolic processes are involved. The goal of this study is to compare a wide array of metabolic processes in 15 people with insomnia and 15 good sleepers. We hypothesize that there will be distinct metabolic processes that are functioning differently in those with insomnia.

Interventions

None listed

Sponsors

Merck Sharp & Dohme LLC
CollaboratorINDUSTRY
University of Pennsylvania
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
25 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

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 Criteria for good sleepers: -subjective report of consistent good sleep

Exclusion criteria

* significant medical or psychiatric illness * diagnosis of a sleep disorder other than insomnia * women who have been pregnant or lactating in the past 6 months * non-fluency in spoken or written English * Current shift work defined as working during the evening or night shift * Current use of medications that affect sleep * BMI \>27

Design outcomes

Primary

MeasureTime frameDescription
Number of Metabolites Elevated Relative to the Other Group.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.

Secondary

MeasureTime frameDescription
Sleep Efficiency Percentage on Overnight Sleep Study1 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.

Countries

United States

Participant flow

Recruitment details

Participants were recruited from the general community and consisted of a group of with chronic insomnia disorder and age- and sex-matched good sleepers.

Participants by arm

ArmCount
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.
15
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.
15
Total30

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyWithdrawal by Subject11

Baseline characteristics

CharacteristicGood SleepersIndividuals With InsomniaTotal
Age, Continuous36.0 years
STANDARD_DEVIATION 7.5
37.0 years
STANDARD_DEVIATION 7.9
36.5 years
STANDARD_DEVIATION 7.7
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants3 Participants4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
14 Participants12 Participants26 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Gender
Female
10 Participants10 Participants20 Participants
Gender
Male
5 Participants5 Participants10 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
2 Participants1 Participants3 Participants
Race (NIH/OMB)
Black or African American
2 Participants4 Participants6 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants1 Participants2 Participants
Race (NIH/OMB)
White
10 Participants9 Participants19 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 160 / 16
serious
Total, serious adverse events
0 / 160 / 16

Outcome results

Primary

Number of Metabolites Elevated Relative to the Other Group.

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.

Time frame: 48 hours

ArmMeasureValue (NUMBER)
Individuals With InsomniaNumber of Metabolites Elevated Relative to the Other Group.13 Number of metabolites elevated
Good SleepersNumber of Metabolites Elevated Relative to the Other Group.9 Number of metabolites elevated
Secondary

Sleep Efficiency Percentage on Overnight Sleep Study

Participants 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.

Time frame: 1 night

ArmMeasureValue (MEAN)Dispersion
Individuals With InsomniaSleep Efficiency Percentage on Overnight Sleep Study75.8 % sleep efficiencyStandard Deviation 14.6
Good SleepersSleep Efficiency Percentage on Overnight Sleep Study80.7 % sleep efficiencyStandard Deviation 9.8

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026