Infrared Photomodulation Therapy for Seasonal Affective Disorder

February 9, 2021 updated by: ProofPilot

Joovv for Seasonal Affective Disorder

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10003
        • ProofPilot (Virtual Study: https://proofpilot.com)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline to 90 day
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
Baseline to 90 day
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
Baseline to 90 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ProofPilot

Collaborators

Joovv

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 27, 2020

Primary Completion (ACTUAL)

May 31, 2020

Study Completion (ACTUAL)

July 1, 2020

Study Registration Dates

First Submitted

January 25, 2020

First Submitted That Met QC Criteria

January 29, 2020

First Posted (ACTUAL)

January 31, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 11, 2021

Last Update Submitted That Met QC Criteria

February 9, 2021

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2393

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

currently no plans.

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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