Sleep in Adults With Down Syndrome and Alzheimer's Disease (NCT03942341) | Clinical Trial Compass
UnknownNot Applicable
Sleep in Adults With Down Syndrome and Alzheimer's Disease
Spain90 participantsStarted 2019-05-08
Plain-language summary
RATIONALE of the project. Adults with Down syndrome (DS) present severe sleep disorders that are under recognized by caregivers. Aging in DS population increases the prevalence of both Obstructive Sleep Apnea (OSA) and Alzheimer´s disease (AD) dementia at much higher rates than in the general population. AD increases the risk of sleep disturbances and OSA, which in turn worsen cognitive performance and behavioral function.
Our hypothesis is that adults with DS and AD dementia will present a higher prevalence of sleep disorders (sleep disruption, sleep circadian disorders and OSA) than in DS without dementia.
There are no data evaluating nocturnal sleep in adults with DS with AD dementia.
The main objective is to evaluate the prevalence of sleep disturbances in adult subjects with DS and AD dementia, by means of subjective and objectives sleep measures.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects of both sexes with ages over 18 years old with DS.
* Subjects will have to be able to understand and accept the study procedures and sign an informed consent (patient and or guardian).
* Only subjects with mild and moderate mental retardation according to ICD-10criteria (IQ scores\> 34).
* Subjects with dementia: subjects with acquired cognitive impairment (assessed by longitudinal neuropsychological tests and/or anamnesis to the family). Absence of comorbid psychiatric disorders (major depressive disorder, bipolar disorder, schizophrenia, autism or behavioral disorders).
Exclusion Criteria:
* Don't meet Inclusion Criteria
* Severe mental retardation
* History of conditions that could affect brain structure or function, such as stroke or traumatic brain injury
* Patients in treatment with CPAP
* New psychoactive drugs in the last three months preceding the survey.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sleep Efficiency
Timeframe: 4 weeks
Trial details
NCT IDNCT03942341
SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau