Effect of CPAP Treatment in Cognition in Adults With DS and OSA
NCT ID: NCT04198493
Last Updated: 2019-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2019-12-31
2021-11-30
Brief Summary
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In general population, continuous positive airway pressure (CPAP), the gold Standard treatment for OSA, partially reverses cognitive impairment secondary to OSA. CPAP treatment, however, is not regularly proposed in adults with DS and OSA. It is usually presumed both by caregivers and physicians, that DS patients will not tolerate or adapt to the treatment, and that they would not benefit much more from CPAP treatment. Therefore, data about the feasibility and impact of CPAP treatment on cognitive function in this population is lacking.
The main objective of this study is to investigate cognitive performance in adults with DS and OSA, the corresponding functional brain changes and their reversibility with CPAP treatment.
Detailed Description
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Objectives:
The general objective is to evaluate cognitive and/or behavioural dysfunction in adults with Down syndrome that can improve with CPAP treatment.
* By evaluating sleep, cognitive function and behaviour aspects in adults with Down syndrome with and without OSA.
* By assessing the changes in sleep, in cognitive, behavioural function, and brain connectivity measures after 6 month of treatment in subjects with DS and severe OSA.
Secondary objectives:
* Assess the relationship between the severity of OSA (AHI, hypoxemia, sleep fragmentation) and severity in cognitive impairment.
* Identify possible sleep and anthropometric parameters that could suggest a worsening in cognitive function in subjects with DS and OSA.
Methodology:
Open pilot study with randomized therapeutic intervention of parallel groups and blind evaluation in neuropsychological assessment.
Patients with severe OSA will be randomized to i) conservative treatment (CT) or to ii) CPAP and conservative treatment.
Patients included in the study will be monitored and followed for 6 months. Patients with severe OSA will perform follow up visits to monitor the objective compliance and side effects of the treatment in the 1st, 3rd and 6th month.
At baseline and after 6 months of treatment, in the three groups of subjects (i) Subjects without OSA, ii) Subjects with OSA and CPAP treatment, and iii) Subjects with OSA+ TC treatment , it will be performed:
1. Sleep evaluation:
Subjective sleep quality (Pittsburgh sleep quality index) and daytime Somnolence (Epworth Sleepiness Scale) Nocturnal sleep by polysomnography (PSG) Sleep-wake pattern by actigraphy
2. Neurocognitive function with an extensive neuropsychological battery assessing mainly memory, attention and executive functions for DS population. (CAMCOG-DS, Cued Recall Test (CRT), different subtests of the Barcelona Test battery: orientation in person, time and space, language items (comprehension, reading and writing), verbal abstraction and oculomotor praxis, cats and dogs test, Attention cancellation test, verbal fluency test.
3. Measures of cerebral functional connectivity: through measures of consistency, mutual information, probability of synchronization and transfer entropy.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Continuous Positive Airway Pressure(CPAP)
Patients with CPAP treatment. Titration will be performed by polysomnography CPAP to determine the optimal treatment pressure.
This group will also be instructed in sleep hygiene and dietary counseling
Intervention:
Device: CPAP Other: Conservative treatment for OSA
CPAP
CPAP treatment every night plus conservative treatment for OSA: sleep hygiene and dietary counseling
CONSERVATIVE TREATMENT for OSA
Conservative treatment for OSA: sleep hygiene and dietary counseling
CONSERVATIVE TREATMENT for OSA
Sleep hygiene and dietary counseling. Sleep hygiene (regular sleep schedule, physical exercise) and dietary counseling Intervention: Other: Conservative treatment for OSA
CONSERVATIVE TREATMENT for OSA
Conservative treatment for OSA: sleep hygiene and dietary counseling
Interventions
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CPAP
CPAP treatment every night plus conservative treatment for OSA: sleep hygiene and dietary counseling
CONSERVATIVE TREATMENT for OSA
Conservative treatment for OSA: sleep hygiene and dietary counseling
Eligibility Criteria
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Inclusion Criteria
* A good general health with adequate visual and auditory acuity will be required
* Understanding and accepting the study procedures and signing an informed consent (guardian and / or patient).
* intelligence quotient(IQ) ratio\> 34 (mild and moderate severe intellectual disability according to the International Statistical Classification of Diseases and Related Health Problems, ICD-10, criteria).
* Subjects without dementia: Absence of loss of cognitive functions (demonstrated by the longitudinal administration of neuropsychological tests and verified by family members)
* Absence of psychiatric comorbidity
Exclusion Criteria
* Presence of psychiatric pathology, unstable disease, cardiac or respiratory failure.
* Intake of psychoactive drugs in the three months prior to the study.
* Patients diagnosed with OSA, undergoing treatment with CPAP.
* Subjects with an Epworth Sleep Scale score \> 12
18 Years
ALL
No
Sponsors
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Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
OTHER
Responsible Party
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Locations
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Multidisciplinary Sleep Unit. Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Countries
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Central Contacts
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Facility Contacts
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Sandra Gimenez, MD, PhD
Role: primary
Other Identifiers
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IIBSP-SAH-2019-62
Identifier Type: -
Identifier Source: org_study_id