Sleep in Adults With Down Syndrome and Alzheimer's Disease
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|ClinicalTrials.gov Identifier: NCT03942341|
Recruitment Status : Recruiting
First Posted : May 8, 2019
Last Update Posted : May 10, 2019
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.
|Condition or disease|
|Alzheimer's Disease Obstructive Sleep Apnea Sleep Disturbances|
|Study Type :||Observational|
|Estimated Enrollment :||90 participants|
|Official Title:||The Impact of Alzheimer's Disease on Sleep in Adults With Down Syndrome|
|Actual Study Start Date :||May 8, 2019|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||December 2020|
Adult subjects with Down syndrome and Alzheimer Disease
Patients will be included from the 6 centers of the Horizon 21 european consortium. Horizon 21 consortium consists of DS cohorts from Spain (the Down Alzheimer Barcelona Neuroimaging Initiative -DABNI). France (the TriAl 21 at Jérôme Lejeune Institute in Paris), the UK (The LonDowns consortium and Dementia in Down's Syndrome (DiDS) in Cambridge), the Netherlands (the Rotterdam DS cohort) and Germany (AD21 in Munich), with a combined total of more than 1,000 older participants with DS to pool data and bioresources to address current gaps in knowledge about AD in DS.
All participants will be included after obtaining a written informed consent approved by the ethics committee. A total of 90 DS subjects with AD dementia of both sexes and good general condition will be included. The presence of a family member will be required as well as a sufficient visual and hearing acuity.
- Sleep Efficiency [ Time Frame: 4 weeks ]The ratio of total sleep time (TST) to time in bed (TIB)
- The apnea/hypopnea index (AHI) [ Time Frame: 4 weeks ]the sum of all apneas (> 90% reduction in airflow for >10 seconds) and all hypopneas (airflow reduction greater than 30% for at 11 least 10 seconds with an oxygen saturation decrease of approximately 3% or a cortical awakening) per hour of sleep, and mean oxygen saturation during the night (Sp02)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03942341
|Hospital de la Santa Creu i Sant Pau||Recruiting|
|Barcelona, Spain, 08025|
|Contact: Sandra Gimenez, MD, PhD +34935537324 firstname.lastname@example.org|