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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04251000
Other study ID # 2393
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 27, 2020
Est. completion date July 1, 2020

Study information

Verified date January 2020
Source ProofPilot
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

During winter months in northern latitudes use of Joovv device on self-reported non-clinical mental health (aka mood), sleep and energy levels. Participants will also submit Withings and Oura activity and sleep data.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date July 1, 2020
Est. primary completion date May 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - history of mental health issues including clinical depression - US based - reasonably active individuals (self report run/gym 3x per week or more) Exclusion Criteria: - average daily high temperature in zipcode above 60 degrees through end of March

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Joovv Mini
the smallest photomodulation device in the Joovv infrared light product line.

Locations

Country Name City State
United States ProofPilot (Virtual Study: https://proofpilot.com) New York New York

Sponsors (2)

Lead Sponsor Collaborator
ProofPilot Joovv

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary change self report mood as assessed by Warwick Edinburgh sleep scale non clinical measures of mood controlled for environmental temperature and daylight Baseline to 90 day
Primary Change in Sleep Duration and Sleep Quality as measured by consumer connected health device Measures of sleep and sleep quality as by a Withings or Oura Ring connected health device Baseline to 90 day
Primary Change in activity levels as measured by consumer connected health devices Measures of activity levels as by WIthings our Oura connected health devices Baseline to 90 day
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