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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

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.

Condition or disease Intervention/treatment Phase
Seasonal Affective Disorder Device: Joovv Mini Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Official Title: Joovv for Seasonal Affective Disorder
Actual Study Start Date : February 27, 2020
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Joovv Pilot Experimenta Arm
Individuals will receive 90 day access to the Joovv infrared mini light device.
Device: Joovv Mini
the smallest photomodulation device in the Joovv infrared light product line.




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT04251000


Contacts
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Contact: Matthew M Amsden 323-284-4626 crew@proofpilot.com

Locations
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United States, New York
ProofPilot (Virtual Study: https://proofpilot.com) Recruiting
New York, New York, United States, 10003
Contact: Matthew Amsden    323-284-4626    crew@proofpiot.com   
Sponsors and Collaborators
ProofPilot
Joovv
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Responsible Party: ProofPilot
ClinicalTrials.gov Identifier: NCT04251000    
Other Study ID Numbers: 2393
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: March 23, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: currently no plans.

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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
Additional relevant MeSH terms:
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Mood Disorders
Seasonal Affective Disorder
Mental Disorders
Depressive Disorder