The Poweroff Sleep Study

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.

Study Overview

• Status: Completed
• Conditions: Sleep
• Intervention / Treatment: Dietary supplement: POWEROFF Capsule; Dietary supplement: Placebo Capsule

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PowerOff; PowerOff is a nutraceutical and a blend of nine ingredients for sleep, including: melatonin; California Poppy; L-Cystine; Glycine; and Magnolia Officinalis	Dietary supplement: POWEROFF Capsule; blend of California Poppy Aerial Part Extract, L-Cystine, L-Theanine,GABA (proprietary Phosphatidylcholine-Palmitic Acid-Oleic Acid Complex), 5-HTP, Magnolia Officinalis Bark Extract, Glycine, Melatonin with 0.5mg of Vitamin B6 (as pyridoxal-5-phosphate).
Placebo Comparator: Placebo; 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	Dietary supplement: Placebo Capsule; Composition of the placebo is 100% organic rice flour, manufactured at a facility New York State licensed to produce pharmaceuticals. Capsules will be instructed to commence on day 7 of the study after baseline appointment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in score on Pittsburgh Sleep Quality Index (PSQI)	measures quality and pattern of sleep in adults. It differentiates "poor" from "good" sleep quality	12 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Duration	collected objectively via the sleep monitoring actigraphy wristwatch	12 Days
Sleep Duration	collected subjectively using self-reported questionnaires	12 Days

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Girardin Jean-Louis, PhD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): April 24, 2018
• Study Completion (Actual): April 24, 2018

Study Registration Dates

• First Submitted: November 21, 2017
• First Submitted That Met QC Criteria: December 4, 2017
• First Posted (Actual): December 6, 2017

Study Record Updates

• Last Update Posted (Actual): May 22, 2018
• Last Update Submitted That Met QC Criteria: May 21, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 17-01020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No