Smart Light Therapy Glasses for Sleep and Mental Wellness

NCT07168954 | Completed DMC

• 1 other identifier: 43406
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

A pair of smart light therapy glasses (Lumos Glasses) was engineered to control the amount of blue light exposure at a person's eyes through a battery powered light source and nano-coating that reflect blue light. The research aims to study the effects of this pair of light therapy glasses on depression and sleep. In addition, the research aims to study the effects of duration of use and its correlation with depression and sleep improvements.

Conditions

Depression; Sleep Disturbance

Outcome Measures

Primary Outcomes (2)

• Montgomery Asberg Depression Rating Scale (MADRS) Improvements

  Improvement of depression rating post intervention

  8 weeks, assessed by clinical team at week 0, 4 and 8

• PROMIS-Sleep Disturbance-Short Form

  Improvement of patient reported sleep rating post intervention

  8 weeks, assessed by clinical team at week 0, 4 and 8, self assessed at week 1, 2 ,3, 5, 6, 7

Secondary Outcomes (2)

• Reaction Time Test

  8 weeks, self assessed weekly via the smartphone app at 8pm

• Memory test

  8 weeks, self assessed weekly via the smartphone app at 8pm

Study Arms (2)

Treatment group

ACTIVE COMPARATOR

The treatment group receives fully operational light therapy glasses, with an optimal light output of 500-700 melanopic lux during full power. The users are recommended to wear the glasses for as long as possible during the day, with a minimum requirement of 20 minutes per day. After 8 weeks, this group is cross-overed to receive the placeobo (low dose 50-70 melanopic lux) treatment for another 8 weeks.

Device: Lumos Glasses

control group

PLACEBO COMPARATOR

The control group receives placebo operational light therapy glasses, operating at 50-70 melanopic lux during full power. The users are recommended to wear the glasses for as long as possible during the day, with a minimum requirement of 20 minutes per day. At week 8, the glasses ramp up to the full 500-700 melanopic lux and becomes equivalent to the active comparator group.

Device: Lumos Glasses

Interventions

Lumos Glasses DEVICE

The Lumos Glasses provided tailored blue light therapy and blue light filtering based on the time of day and the user's ambient light conditions. It combines the effect of bright blue light therapy and blue light blocking.

Treatment group; control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults, any gender, 18+ years old, residing in Ontario Montgomery Asberg Depression Rating Scale Score \> 7 or PROMIS score \>25 Spend on average less than 2 hours outdoors daily.

You may not qualify if:

• MADRS Score above 45, or MADRS suicide score is 5 or 6 People with eye disorders or previous eye surgeries. People who have cataracts, macular degeneration, diabetic retinopathy, or other eye disorders. People taking light sensitizing medication. People with bipolar, psychotic disorders or a history of these disorders. People with epilepsy, or history of epilepsy. People with electronic implants, such as pacemakers. Prescription glasses wearers, except for people who can self-supply contact Page 6 of 40 lenses for the duration of the study. People who do not have an iOS or Android based smartphone Shift workers who work night shift or rotating shifts with night shifts

Sponsors & Collaborators

• University of Waterloo: lead
• Lumos Health Inc.: collaborator

Study Sites (1)

University of Waterloo

Waterloo, Ontario, N2L3G1, Canada

Location

Related Links

• Website of the Lumos Glasses product

MeSH Terms

Conditions

Depression; Parasomnias

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Jonathan M Oakman, Phd, Psychology

  University of Waterloo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Fully blinded study with participants and clinical assessment team blinded. Investigators and outcome assessors access only coded data that masks the interventional after the study to perform analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The intervention group receives full dose light therapy for the full 8 weeks. The control group receives placebo light therapy from week 1 to week 4, followed by full dose light therapy from week 4 to week 8

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: September 11, 2025
• Study Start: September 3, 2024
• Primary Completion: July 14, 2025
• Study Completion: July 14, 2025
• Last Updated: September 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: The data will be available upon publication and will be stored for 25 years
• Access Criteria: Open access

Locations

CA (1)