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The goal of this clinical trial is to assess differences in the fecal microbiota and metabolome associated with insufficient and sufficient sleep, and to evaluate the response and recovery of the microbiota to changes in participant sleep profiles.
Researchers will compare the effect of sleep intervention on both insufficient and sufficient sleepers to identify differences in fecal microbiota structure and function between cohorts during habitual sleep and during the sleep alteration intervention period..
Participants will be assigned to one of two cohorts based on their current sleep habits. Cohort 1 are participants who have insufficient sleep at baseline; this cohort will be assigned to spend 1.5 hours more in bed per night. Cohort 2 are participants who have sufficient sleep at baseline; this cohort will be assigned to spend 1.5 hours less in bed per night. The sleep intervention lasts for 14 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Active Comparator | Cohort 1 are participants who have insufficient sleep at baseline; this cohort will be assigned to spend 1.5 hours more in bed per night. |
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| Cohort 2 | Active Comparator | Cohort 2 are participants who have sufficient sleep at baseline; this cohort will be assigned to spend 1.5 hours less in bed per night. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Increase sleep by 90 minutes | Behavioral | For 14 days, participants will increase their nightly sleep by 90 minutes. |
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| Measure | Description | Time Frame |
|---|---|---|
| Differences in the fecal microbiota of individuals with sufficient and insufficient sleep. | Measure changes in microbial abundance and diversity from baseline to the end of the study in those individuals who have sufficient sleep compared to those with insufficient sleep. This is comparing the sufficient sleep group to the insufficient sleep group across all study periods. | From Day 1 to Day 28 |
| To evaluate the response of the microbiota to changes in participant sleep duration. | Measure changes in gut microbiota within the individual during times of sufficient sleep compared to when they are getting insufficient sleep.This is measuring the change within individual participants before the intervention and after. | From Day 1 to Day 28 |
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Inclusion Criteria:
Cohort specific inclusion criteria:
Cohort 1 (Insufficient Sleep)
Participants must meet all general inclusion criteria PLUS:
Cohort 2 (Sufficient Sleep)
Participants must meet all general inclusion criteria PLUS:
Exclusion:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Global Life Research Network | Not yet recruiting | Miami | Florida | 33155 | United States |
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| Decrease sleep by 90 minutes | Behavioral | For 14 days, participants will decrease their nightly sleep by 90 minutes. |
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| Lindus Health | Recruiting | Boston | Massachusetts | 02111 | United States |
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| AccuMed | Not yet recruiting | Garden City | New York | 11530 | United States |
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