Metabolomics of Insomnia-Related Hyperarousal

NCT ID: NCT01957111

Last Updated: 2017-01-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Primary Insomnia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Individuals with insomnia

No interventions assigned to this group

Good sleepers

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Philip Gehrman, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 29522222 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MISP-50802

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Chronic Sleep Restriction
NCT01493661 COMPLETED