Effect of CPAP Treatment in Cognition in Adults With DS and OSA

NCT04198493 | Unknown DMC

• 1 other identifier: IIBSP-SAH-2019-62
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Adults with Down syndrome (DS) have a high prevalence of obstructive sleep apnea (OSA), which may worsen cognitive performance. 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.

Conditions

Obstructive Sleep Apnea

Keywords

Down Syndrome; Polysomnography

Outcome Measures

Primary Outcomes (2)

• Assessment of the changes on cognitive attentional tasks

  psychomotor speed (in seconds) performing an attentional task

  Baseline and after 6 months of treatment

• Changes in cerebral functional connectivity

  Significant probability maps (SPM) showing statistical changes on connectivity measures between sleep stages

  Baseline and after 6 months of treatment

Study Arms (2)

Continuous Positive Airway Pressure(CPAP)

EXPERIMENTAL

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

Device: CPAP; Other: CONSERVATIVE TREATMENT for OSA

CONSERVATIVE TREATMENT for OSA

ACTIVE COMPARATOR

Sleep hygiene and dietary counseling. Sleep hygiene (regular sleep schedule, physical exercise) and dietary counseling Intervention: Other: Conservative treatment for OSA

Other: CONSERVATIVE TREATMENT for OSA

Interventions

CPAP DEVICE

CPAP treatment every night plus conservative treatment for OSA: sleep hygiene and dietary counseling

Continuous Positive Airway Pressure(CPAP)

CONSERVATIVE TREATMENT for OSA OTHER

Conservative treatment for OSA: sleep hygiene and dietary counseling

CONSERVATIVE TREATMENT for OSA; Continuous Positive Airway Pressure(CPAP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects of both sexes with ages over 18 years old with DS.
• 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

You may not qualify if:

• Severe intellectual disability (due to limitations in cognitive tests)
• 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

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead

Study Sites (1)

Multidisciplinary Sleep Unit. Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Down Syndrome

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

SANDRA GIMENEZ BADIA, MD, PhD

CONTACT

+34935537855; sgimenez@santpau.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open pilot study with randomized therapeutic intervention of parallel groups and blind evaluation in neuropsychological assessment.

Study Record Dates

• First Submitted: November 28, 2019
• First Posted: December 13, 2019
• Study Start: December 1, 2019
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2021
• Last Updated: December 17, 2019

Record last verified: 2019-12

Locations

ES (1)