NCT04251000

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 31, 2020

Completed
27 days until next milestone

Study Start

First participant enrolled

February 27, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

February 11, 2021

Status Verified

January 1, 2020

Enrollment Period

3 months

First QC Date

January 25, 2020

Last Update Submit

February 9, 2021

Conditions

Seasonal Affective Disorder

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (1)

Joovv Pilot Experimenta Arm

EXPERIMENTAL

Individuals will receive 90 day access to the Joovv infrared mini light device.

Device: Joovv Mini

Interventions

Joovv MiniDEVICE

the smallest photomodulation device in the Joovv infrared light product line.

Joovv Pilot Experimenta Arm

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • history of mental health issues including clinical depression
  • US based
  • reasonably active individuals (self report run/gym 3x per week or more)

You may not qualify if:

  • average daily high temperature in zipcode above 60 degrees through end of March

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ProofPilot (Virtual Study: https://proofpilot.com)

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Seasonal Affective Disorder

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
This is a single arm unblineded effort.
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Single arm pilot study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2020

First Posted

January 31, 2020

Study Start

February 27, 2020

Primary Completion

May 31, 2020

Study Completion

July 1, 2020

Last Updated

February 11, 2021

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

currently no plans.

Locations

US(1)