The Poweroff Sleep Study

NYU Langone Health

Status: Completed

Conditions: Sleep

Treatments: Dietary Supplement: POWEROFF Capsule; Dietary Supplement: Placebo Capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT03364101

17-01020

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

PowerOff

Experimental group

Description:

PowerOff is a nutraceutical and a blend of nine ingredients for sleep, including: melatonin; California Poppy; L-Cystine; Glycine; and Magnolia Officinalis

Treatment:

Dietary Supplement: POWEROFF Capsule

Placebo

Placebo Comparator group

Description:

The placebo pill will be manufactured at the same facility and appear identical in all aspects. However, the control agent will feature non-active ingredients with regards to sleep.Capsules will be instructed to commence on day 7 of the study after baseline appointment

Treatment:

Dietary Supplement: Placebo Capsule