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Not yet recruiting NCT07485153

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

— Observational Alzheimer's Disease Early Alzheimer's Disease Memory Problems

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mobile EEG, Activity Monitor, Sleep Study.
Who it may be relevant to
Registry conditions: Alzheimer's Disease, Early Alzheimer's Disease, Memory Problems. Basic parameters: 55 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Singapore
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Device Mobile EEG
    Device measures electrical activity in the brain, pulse rate, blood oxygen saturation levels, changes in blood flow and volume, motion and snoring.
  • Device Activity Monitor
    Device monitors physical movement.
  • Device Sleep Study
    In-Laboratory overnight assessment using EEG, electromyography to measure muscle movement, eye movement, electrical activity in the heart, blood oxygen saturation levels and breathing levels.

Primary outcome measures

  • Percentage of Agreement between Participants with the Same Results in Sleep Staging Using EEG and Sleep Study [Time frame: Night 1, Night 2]

Eligibility criteria

Inclusion criteria

  • Have mild cognitive impairment, subjective memory complaints, or normal cognition.
  • Evidence of the presence of Alzheimer's pathology as measured by amyloid positron emission tomography (PET), cerebrospinal fluid biomarkers (amyloid beta and tau), or blood biomarkers.
  • Montreal Cognitive Assessment (MoCA) score of 24 or greater.
  • Clinical Dementia Rating Scale (CDR) global score of 0 or 0.5.
  • Able to provide signed informed consent.
  • On stable medications (including those for Alzheimer's disease) for 30 days before the first recording night of Study Period 1, and willing to remain on stable therapy during the study.
  • Must have a study partner who knows the participant well and can accompany the participant at visits where informant-rated scales are administered.

Exclusion criteria

  • Severe illness that in the investigator's judgement would adversely affect the participant's participation in the study.
  • Skin illness that may interfere with study assessments.
  • Has a pacemaker or implantable cardioverter defibrillator.
  • Diagnosed with a sleep disorder.
  • Has irregular circadian patterns (works night shifts, etc.).
  • Is pregnant or lactating/breastfeeding at time of screening.
  • Use of sleep aid medications (such as melatonin, Ambien, Lunestra) or other medications or substances that could affect sleep (alcohol, cannabinoids, or opioids) on nights of in-clinic and at-home recordings.
  • Currently enrolled in another clinical study involving an investigational product or other type of medical research judged not to be scientifically or medically compatible with this study.
  • People who habitually spend less than 5 hours in bed per night.
  • No alcohol will be allowed at least 24 hours before the use of the EEG and throughout the clinical assessment period.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Singapore · 1 center
  • Lilly Centre for Clinical Pharmacology — Singapore

Identifiers

NCT: NCT07485153 · 27283 · H7I-MC-S033

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗