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The Poweroff Sleep Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03364101
Recruitment Status : Completed
First Posted : December 6, 2017
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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

Condition or disease Intervention/treatment Phase
Sleep Dietary Supplement: Placebo Capsule Dietary Supplement: POWEROFF Capsule Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: The Poweroff Study
Actual Study Start Date : October 1, 2017
Actual Primary Completion Date : April 24, 2018
Actual Study Completion Date : April 24, 2018

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.




Primary Outcome Measures :
  1. Change in score on Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 12 Days ]
    measures quality and pattern of sleep in adults. It differentiates "poor" from "good" sleep quality


Secondary Outcome Measures :
  1. Sleep Duration [ Time Frame: 12 Days ]
    collected objectively via the sleep monitoring actigraphy wristwatch

  2. Sleep Duration [ Time Frame: 12 Days ]
    collected subjectively using self-reported questionnaires



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03364101


Locations
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United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Girardin Jean-Louis, PhD NYU Langone Health

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03364101     History of Changes
Other Study ID Numbers: 17-01020
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018

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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