The Poweroff Sleep Study

NCT ID: NCT03364101

Last Updated: 2018-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2018-04-24

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.

Conditions

Sleep

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

PowerOff

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

Group Type: EXPERIMENTAL

POWEROFF Capsule

Intervention Type: DIETARY_SUPPLEMENT

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

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

Group Type: PLACEBO_COMPARATOR

Placebo Capsule

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: 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).

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Girardin Jean-Louis, PhD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

17-01020

Identifier Type: -

Identifier Source: org_study_id