Metabolomics of Insomnia-Related Hyperarousal

NCT01957111 | Completed Results

• 1 other identifier: MISP-50802
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Insomnia

Outcome Measures

Primary Outcomes (1)

• Number of Metabolites Elevated Relative to the Other Group.

  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.

  48 hours

Secondary Outcomes (1)

• Sleep Efficiency Percentage on Overnight Sleep Study

  1 night

Study Arms (2)

Individuals with insomnia

Good sleepers

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with primary insomnia (n=15) and matched good sleepers (n=15)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19101, United States

Location

Related Publications (1)

• Gehrman P, Sengupta A, Harders E, Ubeydullah E, Pack AI, Weljie A. Altered diurnal states in insomnia reflect peripheral hyperarousal and metabolic desynchrony: a preliminary study. Sleep. 2018 May 1;41(5):zsy043. doi: 10.1093/sleep/zsy043.

  PMID: 29522222 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Results Point of Contact

• Title: Philip Gehrman
• Organization: University of Pennsylvania

gehrman@exchange.upenn.edu

215-746-3578

Study Officials

• Philip Gehrman, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2013
• First Posted: October 8, 2013
• Study Start: October 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: January 11, 2017
• Results First Posted: January 11, 2017

Record last verified: 2016-11

Locations

US (1)