The Poweroff Sleep Study



Status:Completed
Conditions:Insomnia Sleep Studies
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 65
Updated:5/24/2018
Start Date:October 1, 2017
End Date:April 24, 2018

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The Poweroff Study

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 actigraphy watches that collect objective measures of sleep, such as total sleep time,
and these data points will be compared pre- and post-study.


Inclusion Criteria:

- 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 Criteria:

- 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.
We found this trial at
1
site
550 1st Ave
New York, New York 10016
(212) 263-7300
Principal Investigator: Jean-Louis Girardin, PhD
Phone: 646-501-2607
New York University School of Medicine NYU School of Medicine has a proud history that...
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