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Trial record 69 of 165 for:    trisomy21 NOT prenatal

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
Sponsor:
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief 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.


Condition or disease
Alzheimer's Disease Obstructive Sleep Apnea Sleep Disturbances

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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


Group/Cohort
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.




Primary Outcome Measures :
  1. Sleep Efficiency [ Time Frame: 4 weeks ]
    The ratio of total sleep time (TST) to time in bed (TIB)


Secondary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Spain
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08025
Contact: Sandra Gimenez, MD, PhD    +34935537324    sgimenez@santpau.cat   
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT03942341     History of Changes
Other Study ID Numbers: IIBSP-ASD-2019-15
First Posted: May 8, 2019    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
Down syndrome
Alzheimer's disease
obstructive sleep apnea
Polysomnography

Additional relevant MeSH terms:
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Down Syndrome
Alzheimer Disease
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Dyssomnias
Sleep Wake Disorders
Parasomnias
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Signs and Symptoms