RECRUITING

Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Participants will randomly be placed into one of four groups and experience one of the four following conditions: (1) a placebo light that provides a 40 hertz (Hz) flicker (rhythmic light \[RL\]); (2) a placebo light with a random flicker (placebo condition for rhythmic light); (3) a light source that will stimulate the circadian system and provides a 40 Hz flicker (RL); or (4) a light source that will stimulate the circadian system and provides a random flicker (placebo condition for rhythmic light). Following a baseline week, participants will experience his/her assigned lighting condition for two hours in the morning for 8 weeks. After a 4-week washout period, a final round of assessments will be obtained. Study assessments (except for the Pittsburgh Sleep Quality Index and Montreal Cognitive Assessment) will be collected at the end of each week, for a total of 8 assessments.

Official Title

Phase 2 - The Use of Rhythmic Light Therapy to Entrain Gamma Oscillations and the Circadian System in Patients With Alzheimer's Disease

Quick Facts

Study Start:2023-08-22
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05016219

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.

Ages Eligible for Study:55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants must be diagnosed with mild cognitive impairment or mild Alzheimer's disease, as defined by a Montreal Cognitive Assessment score between 17 and 25;
  2. * Have sleep disturbance indicated by a score \>5 on the Pittsburgh Sleep Quality Index
  3. * Participants must reside in their homes, independent living, or assisted living facilities
  1. * Participants taking sleep medication
  2. * Residence in a skilled nursing facility or long-term care
  3. * Obstructing cataracts, macular degeneration, and blindness
  4. * Severe sleep apnea or restless leg syndrome
  5. * History of severe epilepsy

Contacts and Locations

Study Contact

Barbara Plitnick, BSN
CONTACT
518-242-4603
barbara.plitnick@mountsinai.org
Mariana Figueiro, PhD
CONTACT
518-366-9306
mariana.figueiro@mountsinai.org

Principal Investigator

Mariana Figueiro, PhD
PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

Light and Health Research Center
Menands, New York, 12204
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

  • Mariana Figueiro, PhD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

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 Registration Dates

Study Start Date2023-08-22
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2023-08-22
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • Light Treatment
  • Circadian Rhythms
  • Gamma Wave Entrainment
  • Rhythmic Light
  • Sleep
  • Cognition

Additional Relevant MeSH Terms

  • Mild Cognitive Impairment