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Infrared Photomodulation Therapy for Seasonal Affective Disorder

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04251000
Recruitment Status : Recruiting
First Posted : January 31, 2020
Last Update Posted : March 23, 2020
Sponsor:
Collaborator:
Joovv
Information provided by (Responsible Party):
ProofPilot

Tracking Information
First Submitted Date  ICMJE January 25, 2020
First Posted Date  ICMJE January 31, 2020
Last Update Posted Date March 23, 2020
Actual Study Start Date  ICMJE February 27, 2020
Estimated Primary Completion Date May 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2020)
  • change self report mood as assessed by Warwick Edinburgh sleep scale [ Time Frame: Baseline to 90 day ]
    non clinical measures of mood controlled for environmental temperature and daylight
  • Change in Sleep Duration and Sleep Quality as measured by consumer connected health device [ Time Frame: Baseline to 90 day ]
    Measures of sleep and sleep quality as by a Withings or Oura Ring connected health device
  • Change in activity levels as measured by consumer connected health devices [ Time Frame: Baseline to 90 day ]
    Measures of activity levels as by WIthings our Oura connected health devices
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Infrared Photomodulation Therapy for Seasonal Affective Disorder
Official Title  ICMJE Joovv for Seasonal Affective Disorder
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Single arm pilot study
Masking: None (Open Label)
Masking Description:
This is a single arm unblineded effort.
Primary Purpose: Prevention
Condition  ICMJE Seasonal Affective Disorder
Intervention  ICMJE Device: Joovv Mini
the smallest photomodulation device in the Joovv infrared light product line.
Study Arms  ICMJE Experimental: Joovv Pilot Experimenta Arm
Individuals will receive 90 day access to the Joovv infrared mini light device.
Intervention: Device: Joovv Mini
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 29, 2020)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2020
Estimated Primary Completion Date May 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Matthew M Amsden 323-284-4626 crew@proofpilot.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04251000
Other Study ID Numbers  ICMJE 2393
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: currently no plans.
Responsible Party ProofPilot
Study Sponsor  ICMJE ProofPilot
Collaborators  ICMJE Joovv
Investigators  ICMJE Not Provided
PRS Account ProofPilot
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP