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Not Yet RecruitingNCT07485153

A Study to Compare Two Different Sleep Tests in Participants With No Symptoms or Early Symptoms of Alzheimer's Disease

A Study to Assess the Use of the Somfit, an Ambulatory Electroencephalogram-Based Digital Health Technology, Compared With Polysomnography to Evaluate Sleep Architecture in Individuals With Asymptomatic or Early Alzheimer's Disease

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
35 (estimated)
Sponsor
Eli Lilly and Company · Industry
Sex
All
Age
55 Years – 85 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to compare the results of two different sleep tests in Alzheimer's patients with no symptoms or early symptoms. Participants will undergo two simultaneous sleep tests (polysomnography) in a sleep laboratory for two nights and one sleep test at home for three nights. For each participant, the study will last at least a week and will last up to three months.

Conditions

Interventions

TypeNameDescription
DEVICEMobile EEGDevice measures electrical activity in the brain, pulse rate, blood oxygen saturation levels, changes in blood flow and volume, motion and snoring.
DEVICEActivity MonitorDevice monitors physical movement.
DEVICESleep StudyIn-Laboratory overnight assessment using EEG, electromyography to measure muscle movement, eye movement, electrical activity in the heart, blood oxygen saturation levels and breathing levels.

Timeline

Start date
2026-03-01
Primary completion
2026-09-01
Completion
2026-09-01
First posted
2026-03-20
Last updated
2026-03-20

Locations

1 site across 1 country: Singapore

Source: ClinicalTrials.gov record NCT07485153. Inclusion in this directory is not an endorsement.