Primary Insomnia
Conditions
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.
Interventions
None listed
Sponsors
Study design
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Metabolites Elevated Relative to the Other Group. | 48 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Efficiency Percentage on Overnight Sleep Study | 1 night | 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. Sleep quality is defined as sleep efficiency, which is calculated at total sleep time / total time spent in bed x 100. It indicates the % of time spent asleep while in bed. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from the general community and consisted of a group of with chronic insomnia disorder and age- and sex-matched good sleepers.
Participants by arm
| Arm | Count |
|---|---|
| Individuals With Insomnia Participants with insomnia met the following Research Diagnostic 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 based or the effects of a substance, as determined by clinical history. In order to exclude individuals with mild insomnia, insomnia had to occur on 3 or more nights per week for three months or longer. A 30-minute criterion was used such that subjects had to report taking 30 minutes or longer to fall asleep and/or spend 30 minutes awake during the night. | 15 |
| Good Sleepers To be considered a good sleeper, participants had to report that they did not have difficulty falling asleep or staying asleep. A 15-minute criterion was used such that subjects had to report taking 15 minutes or less to fall asleep and spend 15 minutes or less awake during the night. | 15 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Good Sleepers | Individuals With Insomnia | Total |
|---|---|---|---|
| Age, Continuous | 36.0 years STANDARD_DEVIATION 7.5 | 37.0 years STANDARD_DEVIATION 7.9 | 36.5 years STANDARD_DEVIATION 7.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 3 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 12 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Gender Female | 10 Participants | 10 Participants | 20 Participants |
| Gender Male | 5 Participants | 5 Participants | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 10 Participants | 9 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 |
Outcome results
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.
Time frame: 48 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Individuals With Insomnia | Number of Metabolites Elevated Relative to the Other Group. | 13 Number of metabolites elevated |
| Good Sleepers | Number of Metabolites Elevated Relative to the Other Group. | 9 Number of metabolites elevated |
Sleep Efficiency Percentage on Overnight Sleep Study
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. Sleep quality is defined as sleep efficiency, which is calculated at total sleep time / total time spent in bed x 100. It indicates the % of time spent asleep while in bed.
Time frame: 1 night
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Individuals With Insomnia | Sleep Efficiency Percentage on Overnight Sleep Study | 75.8 % sleep efficiency | Standard Deviation 14.6 |
| Good Sleepers | Sleep Efficiency Percentage on Overnight Sleep Study | 80.7 % sleep efficiency | Standard Deviation 9.8 |