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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство Mobile EEG
  Device measures electrical activity in the brain, pulse rate, blood oxygen saturation levels, changes in blood flow and volume, motion and snoring.
• Устройство Activity Monitor
  Device monitors physical movement.
• Устройство 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.

Первичные конечные точки

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Сингапур · 1 центр

• Lilly Centre for Clinical Pharmacology — Singapore

Идентификаторы

NCT: NCT07485153 · 27283 · H7I-MC-S033

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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