Trials Sponsors Conditions Drugs Pricing

Conditions

Alzheimer's Disease Sleep Disturbance

Outcome Measures

Primary Outcomes (1)

Sleep Disturbance using the Pittsburgh Sleep Quality Index
The PSQI is used to measure sleep quality and is composed of 19 items that generate 7 component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction). Each subscale is scored 0 to 3. The sum of the 7 component scores yields a single global score with a range of 0 to 21. A higher score indicates higher sleep disturbance
up to week 14

Secondary Outcomes (1)

Sleep efficiency using actigraphy
up to week 14

Study Arms (2)

Active Lighting Intervention

ACTIVE COMPARATOR

Lighting intervention designed to effect the circadian system then will receive the control lighting intervention.

Device: Active Lighting InterventionDevice: Control Lighting Intervention

Control Lighting Intervention

PLACEBO COMPARATOR

Lighting intervention using low light levels designed to not effect the circadian system

Device: Control Lighting Intervention

Interventions

Active Lighting InterventionDevice

Lighting intervention using high light levels designed to effect the circadian system

Active Lighting Intervention

Control Lighting InterventionDevice

Lighting intervention using low light levels designed to not effect the circadian system

Active Lighting Intervention

Eligibility Criteria

Age65 Years+

Sexall

Healthy VolunteersNo

Age GroupsOlder Adult (65+)

You may qualify if:

Diagnosis of Alzheimer's disease or related dementia with a Montreal Cognitive Assessment score \<25
Sleep disturbance with a Pittsburgh Sleep Quality Index score ≥5

You may not qualify if:

Sponsors & Collaborators

Icahn School of Medicine at Mount Sinai
Otherlead

Study Sites (2)

Icahn School of Medicine at Mount Sinai

Albany, New York, 12204, United States

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

MeSH Terms

Conditions

Alzheimer DiseaseParasomnias

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersSleep Wake Disorders

Study Officials

Mariana Figueiro, PhD
Icahn School of Medicine at Mount Sinai
PRINCIPAL INVESTIGATOR

Enrollment

135 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Purpose: TREATMENT
Intervention Model: CROSSOVER
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor

Study Record Dates

First Submitted

April 20, 2023

First Posted

May 1, 2023

Study Start

February 14, 2023

Actual (reported)

Methodology Issues in a Tailored Light Treatment for Persons With Dementia - Aim 2

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Active Lighting Intervention

Control Lighting Intervention

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Active Lighting Intervention

Control Lighting Intervention

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations