A study investigating whether sleep can be measured accurately at home in people with early Alzheimer’s disease

Feasibility of measuring sleep-dependent brain activity at home in people with prodromal and mild Alzheimer's disease to help delay symptoms (SleepAD)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN17814224

Enrollment

100

Registered

2023-03-22

Start date

2023-03-15

Completion date

Unknown

Last updated

2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementias and neurodegeneration, Alzheimers disease Nervous System Diseases

Interventions

SleepAD SUB-STUDY 1 Design: Single centre, prospective observational feasibility study. Setting: Southmead Hospital cognitive disorders clinic and participants’ homes. Screening consultations can be

Eligibility

Sex/Gender

All

Age

50 Years to 120 Years

Inclusion criteria

Inclusion criteria: For Sub-Study 1: 1. Age > 50 years 2. All participants must express that they are willing to take part in this study and adhere to the study procedures 3. Full capacity to consent to involvement 4. Clinical diagnosis of MCI due to AD or mild AD according to standardised criteria For Sub-Study 2: 1. All participants undergoing CSF testing clinically including CSF biomarkers of AD. 2. All participants must express that they are willing to take part in this study and adhere to the study procedures. 3. Full capacity to consent to involvement

Exclusion criteria

Exclusion criteria: For Sub-Study 1 1. Severe medical or psychiatric co-morbidity, which, in the opinion of the investigator, may substantially impact on sleep. 2. Clinically significant sleep disorder as defined by ICD-10 or equivalent pre-dating and / or not related to AD pathology. 3. Diagnosis of dementia other than AD. 4. Montreal Cognitive Assessment (MoCA) < 11/30 For Sub-Study 2 1. Severe medical or psychiatric co-morbidity, which, in the opinion of the investigator, may substantially impact on the ability to tolerate withdrawal of an extra 10ml of blood.

Design outcomes

Primary

Measure	Time frame
Baseline screening only: Sub-study 1: 1.1. Amount of missing data for sleep nights with high density EEG. 1.2. Acceptability ratings for home EEG (Acceptability will be measured using a non-validated experience questionnaire, developed to evaluate acceptability at the end of the study) 1.3. Various sleep metrics, including time spent (in minutes) in different sleep stages as measured from EEG 1.4. Number of datasets for sleep nights with pulse oximetry Sub-study 2: 2.1. Number of lost/degraded blood samples 2.2. Diagnostic accuracy of the separate index tests (Neurofilament light chain, NFL; phosho-tau, p-tau) for Alzheimer’s Disease, at pre-published thresholds, compared to reference standard (Cerebrospinal Fluid, CSF) via AUROC curves. We will also explore heterogeneity in diagnostic accuracy of AD index tests by pre-specified factors listed using cut offs for AD/no AD extrapolated from UCL clinical laboratories. 2.3. The relationship between biomarkers (p-tau and NFL; blood levels measured using validated Single Molecular Array assays of NFL and P-tau-181) and sleep metrics (including Total sleep time [mins], Sleep Latency [mins], Wake After Sleep Onset [mins], Awakening [frequency], Nap duration [mins], Nap [frequency], N1/N2/N3/REM duration [mins], Micro-arousal index, Sleep fragmentation index, Apnea-hypopnea index; measured using a high-density EEG sleep cap and pulse oximeter) in patients who have had both blood biomarkers and high-density EEG.	—

Measure

Time frame

Baseline screening only: Sub-study 1: 1.1. Amount of missing data for sleep nights with high density EEG. 1.2. Acceptability ratings for home EEG (Acceptability will be measured using a non-validated experience questionnaire, developed to evaluate acceptability at the end of the study) 1.3. Various sleep metrics, including time spent (in minutes) in different sleep stages as measured from EEG 1.4. Number of datasets for sleep nights with pulse oximetry Sub-study 2: 2.1. Number of lost/degraded blood samples 2.2. Diagnostic accuracy of the separate index tests (Neurofilament light chain, NFL; phosho-tau, p-tau) for Alzheimer’s Disease, at pre-published thresholds, compared to reference standard (Cerebrospinal Fluid, CSF) via AUROC curves. We will also explore heterogeneity in diagnostic accuracy of AD index tests by pre-specified factors listed using cut offs for AD/no AD extrapolated from UCL clinical laboratories. 2.3. The relationship between biomarkers (p-tau and NFL; blood levels measured using validated Single Molecular Array assays of NFL and P-tau-181) and sleep metrics (including Total sleep time [mins], Sleep Latency [mins], Wake After Sleep Onset [mins], Awakening [frequency], Nap duration [mins], Nap [frequency], N1/N2/N3/REM duration [mins], Micro-arousal index, Sleep fragmentation index, Apnea-hypopnea index; measured using a high-density EEG sleep cap and pulse oximeter) in patients who have had both blood biomarkers and high-density EEG.

—

Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 23, 2026