Status:
COMPLETED
The Poweroff Sleep Study
Lead Sponsor:
NYU Langone Health
Conditions:
Sleep
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The primary objective is to explore the relationship between experimental condition (placebo or PowerOff) and sleep quality between pre-study and post-study. In addition, volunteers will wear actigrap...
Eligibility Criteria
Inclusion
- Sleep/Wake History. Participants must currently maintain a regular sleep/wake schedule (±2 hr average bedtime) and express willingness to continue to follow a regular sleep-wake schedule.
- Drug/Alcohol Use. Participants must be drug-free (including nicotine). No medications (prescription or over the counter) that significantly affect circadian rhythms or sleep are allowed. Subjects must report no history of drug or alcohol dependency to be included in the study.
- Evaluation of Medical Suitability. Only healthy men and women are to be selected for this study. Subjects will be free from any acute, chronic, or debilitating medical conditions. Normality will be established on the basis of self-report clinical history and diagnoses/. Any subject with symptoms of active illness, such as fever, infection, or hypertension, will be excluded.
- Evaluation of Psychiatric/Psychological Suitability. Individuals with a history of psychiatric illnesses or psychiatric disorders will be excluded. Individuals who are unaware of specific psychiatric diagnoses but had a history of treatment with antidepressant, neuroleptic medications, or major tranquilizers will be excluded from the study. Subjects will also be questioned to demonstrate their full understanding of the requirements, demands, and risks of the study and informed of the option to withdraw at any time.
Exclusion
- Older adults are known to experience decreased depth of non-rapid eye movement sleep (NREM), as well as lesser amounts of deep sleep (NREM3), They therefore spend greater amounts of their sleep time in less protected lighter sleep stages. For these reasons, older adults (above age 65) will be excluded from the study.
- Individuals whom have had a negative or paradoxical response to an OTC sleep supplement or OTC sleep medication (Nyquil zzz's, Benadryl, melatonin, valerian, etc.).
- Individuals who are or are planning to become pregnant in the next 60 days.
Key Trial Info
Start Date :
October 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 24 2018
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03364101
Start Date
October 1 2017
End Date
April 24 2018
Last Update
May 22 2018
Active Locations (1)
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1
New York University School of Medicine
New York, New York, United States, 10016