Back to resultsInfrared Photomodulation Therapy for Seasonal Affective Disorder
Primary Purpose
Seasonal Affective Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Joovv Mini
Sponsored by
About this trial
This is an interventional prevention trial for Seasonal Affective Disorder
Eligibility 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
Sites / Locations
- ProofPilot (Virtual Study: https://proofpilot.com)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Joovv Pilot Experimenta Arm
Arm Description
Individuals will receive 90 day access to the Joovv infrared mini light device.
Outcomes
Primary Outcome Measures
change self report mood as assessed by Warwick Edinburgh sleep scale
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
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
Measures of activity levels as by WIthings our Oura connected health devices
Secondary Outcome Measures
Full Information
NCT ID
NCT04251000
First Posted
January 25, 2020
Last Updated
February 9, 2021
Sponsor
ProofPilot
Collaborators
Joovv
1. Study Identification
Unique Protocol Identification Number
NCT04251000
Brief Title
Infrared Photomodulation Therapy for Seasonal Affective Disorder
Official Title
Joovv for Seasonal Affective Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
February 27, 2020 (Actual)
Primary Completion Date
May 31, 2020 (Actual)
Study Completion Date
July 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ProofPilot
Collaborators
Joovv
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Affective Disorder
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single arm pilot study
Masking
None (Open Label)
Masking Description
This is a single arm unblineded effort.
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Joovv Pilot Experimenta Arm
Arm Type
Experimental
Arm Description
Individuals will receive 90 day access to the Joovv infrared mini light device.
Intervention Type
Device
Intervention Name(s)
Joovv Mini
Intervention Description
the smallest photomodulation device in the Joovv infrared light product line.
Primary Outcome Measure Information:
Title
change self report mood as assessed by Warwick Edinburgh sleep scale
Description
non clinical measures of mood controlled for environmental temperature and daylight
Time Frame
Baseline to 90 day
Title
Change in Sleep Duration and Sleep Quality as measured by consumer connected health device
Description
Measures of sleep and sleep quality as by a Withings or Oura Ring connected health device
Time Frame
Baseline to 90 day
Title
Change in activity levels as measured by consumer connected health devices
Description
Measures of activity levels as by WIthings our Oura connected health devices
Time Frame
Baseline to 90 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
ProofPilot (Virtual Study: https://proofpilot.com)
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
currently no plans.
Learn more about this trial
Infrared Photomodulation Therapy for Seasonal Affective Disorder
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