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The Poweroff Sleep Study

Sponsor
NYU Langone Health (Other)
Overall Status
Completed
CT.gov ID
NCT03364101
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
6.7
Actual Duration (Months)
8.9
Patients Per Site Per Month

Study Details

Study Description

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
  • Dietary Supplement: Placebo Capsule
  • Dietary Supplement: POWEROFF Capsule
 N/A

Study Design

Study Type:
Interventional
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 :
Oct 1, 2017
Actual Primary Completion Date :
Apr 24, 2018
Actual Study Completion Date :
Apr 24, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in score on Pittsburgh Sleep Quality Index (PSQI) [12 Days]

    measures quality and pattern of sleep in adults. It differentiates "poor" from "good" sleep quality

Secondary Outcome Measures

  1. Sleep Duration [12 Days]

    collected objectively via the sleep monitoring actigraphy wristwatch

  2. Sleep Duration [12 Days]

    collected subjectively using self-reported questionnaires

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 New York University School of Medicine New York New York United States 10016

Sponsors and Collaborators

  • NYU Langone Health

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT03364101
Other Study ID Numbers:
  • 17-01020
First Posted:
Dec 6, 2017
Last Update Posted:
May 22, 2018
Last Verified:
May 1, 2018
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

Study Results

No Results Posted as of May 22, 2018