Pilot Intervention With Near Infrared Stimulation

Part of paid clinical trials in Tucson, Arizona.

Sponsor
University of Florida
Study ID
NCT03551392
Status
Recruiting
Apply to this trial

Conditions

  • Aging

Eligibility Criteria

Sex
ALL
Age
65 Years - 89 Years
Healthy Volunteers
Accepted

Interventions

  • Medx Console System — DEVICE
    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.
  • Sham Medx Console System — DEVICE
    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.
  • Vielight 810 intranasal stand alone unit — DEVICE
    Daily at home intranasal NIR stimulation sessions, 25 minutes in duration, 4 days each week.
  • Sham Vielight 810 intranasal stand alone unit — DEVICE
    Daily at home intranasal "sham" NIR stimulation sessions, 25 minutes in duration, 4 days each week.

Study Details

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.

Key Dates

Start date
Jun 26, 2019
Status verified
Jan 2025
Primary completion
Apr 30, 2026
Completion
Apr 30, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: NIR -Older Adult
    Older adult participants receive the Medx Console System and the Vielight 810 intranasal stand alone unit. These interventions occur during 16 lab sessions (1.5 hours each) during an 12 week period, plus daily 25 minute 'at home' intranasal stimulation interventions, 4 days each week.
  • Sham Comparator: No Dose NIR-Older Adult
    Older adult participants receive the sham Medx Console System and the sham Vielight 810 intranasal stand alone unit, since the devices deliver no near infrared light. These sham interventions occur during 16 lab sessions (1.5 hours each) during an 12 week period, plus daily 25 minute 'at home' intranasal stimulation interventions, 4 days each week.

Primary Outcome Measure

ARENA, learning and memory change from baseline to post-testing [ Time Frame: Baseline to one-week post intervention (approx Week 14) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of ArizonaTucsonArizona85721-
University of FloridaGainesvilleFlorida32611-

Find similar trials in Tucson, AZ

By research site
University of Arizona· Tucson, AZUniversity of Florida· Gainesville, FL

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