Metabolomics of Insomnia-Related Hyperarousal

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University of Pennsylvania
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: June 10, 2014
Last verified: September 2013
  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.


Estimated Enrollment: 30
Study Start Date: October 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 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
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

Contacts
Contact: Elisabeth Ertel ertel@mail.med.upenn.edu

Locations
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19101
Contact: Elisabeth Ertel       ertel@mail.med.upenn.edu   
Principal Investigator: Philip Gehrman         
Sponsors and Collaborators
University of Pennsylvania
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Philip Gehrman, PhD University of Pennsylvania
  More Information

No publications provided

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: June 10, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 18, 2014