Metabolomics of Insomnia-Related Hyperarousal

Completed

• Conditions: Primary Insomnia

• Registration Number: NCT01957111
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-17
• Study Start: 2013-10
• Study First Submitted QC: 2013-10-07
• Study First Posted: 2013-10-08
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Results First Submitted: 2016-09-23
• Status Verified: 2016-11
• Results First Submitted QC: 2016-11-14
• Last Update Submitted: 2016-11-14
• Results First Posted: 2017-01-11
• Last Update Posted: 2017-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Metabolites Elevated Relative to the Other Group.	48 hours	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.

Secondary Outcome Measures

Name	Time	Method
Sleep Efficiency Percentage on Overnight Sleep Study	1 night	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.

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States