Pilot Intervention With Near Infrared Stimulation

Summary

The current study will test whether age-related cognitive and mood changes in older adults and those will be affected by near infrared (NIR) stimulation. The overall hypothesis, drawn from previous literature, is that exposure to NIR stimulation will have positive effects on brain health and will result in better cognitive and mood performance.

Conditions

• Aging

Interventions

DEVICE

Medx Console System

This intervention delivers near infrared (NIR) light using light emitting diodes applied to the head and via an intranasal applicator for a period of approximately 1.5 hours. A total of 16 sessions take place in the lab over 12 weeks.

DEVICE

Sham Medx Console System

This intervention uses sham application of near infrared light (NIR) using light emitting diodes applied to the head and via an intranasal applicator for a period of approximately 1.5 hours. A total of 16 sessions take place in the lab over 12 weeks.

DEVICE

Vielight 810 intranasal stand alone unit

Daily at home intranasal NIR stimulation sessions, 25 minutes in duration, 4 days each week.

DEVICE

Sham Vielight 810 intranasal stand alone unit

Daily at home intranasal "sham" NIR stimulation sessions, 25 minutes in duration, 4 days each week.

Sponsors & Collaborators

• McKnight Brain Research Foundation

  collaborator UNKNOWN

• University of Arizona

  collaborator OTHER

• University of Florida

  lead OTHER

Principal Investigators

• Dawn Bowers, Ph.D. · University of Florida

• Adam Woods, Ph.D. · University of Florida

• Gene Alexander, Ph.D. · University of Arizona

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Max Age

89 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-06-26

Primary Completion

2026-04-30

Completion

2026-04-30

FDA Device

Yes

Countries

• United States

Study Locations