Metabolomics of Insomnia-Related Hyperarousal

Primary Insomnia Clinical Trial

Official title:

Metabolomics of Insomnia-Related Hyperarousal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01957111
• Other study ID #: MISP-50802
• Status: Completed
• Phase: N/A
• First received: September 17, 2013
• Last updated: May 20, 2016
• Start date: October 2013
• Est. completion date: October 2015

Study information

• Verified date: May 2016
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 55 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Primary Insomnia

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolite profile	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.	48 hours	No
Secondary	Sleep patterns	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.	1 night	No