Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07345767
Eligibility Criteria:
Inclusion Criteria:
1. Be between the ages of 18-60 years old
2. Have a typical sleep schedule of \<=6 hours per night
3. Must have a FitBit device (any model) with Heart Rate Monitor
4. Must have bedtime between 8 pm and 1 am
5. Must have a waketime between 5 am and 10 am
6. Must not have insomnia as determined by diagnosis or score on the Insomnia Severity Index (ISI), or must be treated.
7. Must not have sleep apnea as determined by diagnosis or STOP-BANG scale, or must be treated.
8. Must have a computer or smartphone device for daily sleep diaries.
9. Must have an initial sleep efficiency of at least 85% as determined by sleep diaries and actigraphy.
Exclusion Criteria:
1. Any condition that the PI considers would significantly impede participation in the study.
2. Participant is under 18 years of age or older than 60 years of age
3. Does not own a FitBit device with Heart Rate Monitor
4. Sleep \>6 hours per night.
5. Typical bedtime before 8 pm or after 1 am
6. Typical waketime before 5 am or after 10 am
7. Diagnosed with sleep disorders including insomnia or sleep apnea
8. Diagnosed mental health disorder which may impact sleep (i.e. Bipolar Disorder)
9. Taking medications that may affect sleep.
10. Baseline sleep efficiency less than 85%.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT07345767
Study Brief:
Protocol Section:
NCT07345767