Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Metabolomics of Insomnia-Related Hyperarousal

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01957111
First received: September 17, 2013
Last updated: May 20, 2016
Last verified: May 2016
  Purpose
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
Primary Insomnia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Metabolomics of Insomnia-Related Hyperarousal

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Metabolite profile [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Metabolomics analysis of blood samples will be carried out using Spectroscopy. This approach allows for rapid, unbiased and quantitative metabolic profiles ('fingerprints) to be acquired. Metabolite profiles of individuals with insomnia will be compared to those of good sleepers.


Secondary Outcome Measures:
  • Sleep patterns [ Time Frame: 1 night ] [ Designated as safety issue: No ]
    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.


Enrollment: 30
Study Start Date: October 2013
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Individuals with insomnia
Good sleepers

  Eligibility

Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01957111

Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19101
Sponsors and Collaborators
University of Pennsylvania
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Philip Gehrman, PhD University of Pennsylvania
  More Information

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01957111     History of Changes
Other Study ID Numbers: MISP-50802 
Study First Received: September 17, 2013
Last Updated: May 20, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on September 29, 2016