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Metabolomics of Insomnia-Related Hyperarousal

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ClinicalTrials.gov Identifier: NCT01957111
Recruitment Status : Completed
First Posted : October 8, 2013
Results First Posted : January 11, 2017
Last Update Posted : January 11, 2017
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University of Pennsylvania

Study Description
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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.

Condition or disease
Primary Insomnia

Study Design
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Study Type : Observational
Actual Enrollment : 32 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Metabolomics of Insomnia-Related Hyperarousal
Study Start Date : October 2013
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015
Groups and Cohorts
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Group/Cohort
Individuals with insomnia
Good sleepers


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Individuals with primary insomnia (n=15) and matched good sleepers (n=15)
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01957111


Locations
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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19101
Sponsors and Collaborators
University of Pennsylvania
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Philip Gehrman, PhD University of Pennsylvania
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01957111    
Other Study ID Numbers: MISP-50802
First Posted: October 8, 2013    Key Record Dates
Results First Posted: January 11, 2017
Last Update Posted: January 11, 2017
Last Verified: November 2016
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
 Sleep Wake Disorders
Nervous System Diseases
Mental Disorders