N/A
N=32
Metabolomics of Insomnia-Related Hyperarousal
Primary Insomnia
Bottom Line
View on ClinicalTrials.gov: NCT01957111 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcome: Primary: Number of Metabolites Elevated Relative to the Other Group. — 13; 9 Number of metabolites elevated
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult · 25+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Metabolites Elevated Relative to the Other Group. |
13; 9 | — |
| SECONDARY Sleep Efficiency Percentage on Overnight Sleep Study |
75.8; 80.7 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01957111). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.