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OpenTrials
Completed

NCT Number: NCT01957111

Metabolomics of Insomnia-Related Hyperarousal

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.

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Key information

Conditions

Primary Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19101, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of Metabolites Elevated Relative to the Other Group.

    Time frame: 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 outcomes

  1. Sleep Efficiency Percentage on Overnight Sleep Study

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 8, 2013
Registry last updated
Jan 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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