Obstructive Sleep Apneas in Elderly:Neuroimaging Changes and Neurocognitive Function Before and After Treatment
In the near future more than 20% of the European population will be over 65 years old and the prevalence of obstructive sleep apnea (OSA) in this aged population is known to be higher than 50%. OSA is a risk factor for cognitive dysfunction in middle-aged subjects, but the relationship between cognitive impairment and sleep breathing disorders (SBD) in the elderly has scarcely been observed.
The aim of this study is to investigate cognitive performance in elderly OSA patients, the corresponding brain morphology changes and biological markers and their reversibility with continuous positive airway pressure (CPAP) treatment.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Patients: We will include consecutive patients with a diagnosis of severe OSA (AHI> 30) without significant comorbidities or excessive daytime sleepiness (Epworth ≤ 12). Patients will be randomized to CPAP treatment or conservative treatment.
Methodology: We will assess at baseline and after 3 months of treatment:
- Neuroimaging by MRI
- Neurocognitive function with an extensive neuropsychological battery assessing principally memory, attention and executive functions (Trail-making test A and B, Rey Auditory Verbal Learning Test, Digit span, Digit symbol),
- Biological markers of inflammation and endothelial dysfunction.
Patients included in the study will be monitored and followed for three months. They will be examined at the time of inclusion, after two and six weeks and at the end (12 weeks) for clinical monitoring and the evaluation of adaptation to treatment and compliance.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Catalonia
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Barcelona, Catalonia, Espanha, 08036
- Hospital Clinic Barcelona
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Men and women ≥ 65 years old.
- Patients diagnosed with OSA with an apnea-hypopnea index per hour >30.
- Patients with an Epworth Sleep Scale score ≤ 12 (without excessive daytime sleepiness).
- Signed written informed consent.
Exclusion Criteria:
- Patients with severe chronic diseases: cardiovascular or pulmonary, neurological (stroke, epilepsy, head injury...) or psychiatric.
- Any current significant systemic illness or unstable medical condition that could lead to difficulty in complying with the protocol or may, in the opinion of the investigator, compromise the conclusions.
- Mini Mental State Exam (MMSE) <24.
- Any MRI exclusions - presence of aneurysm clips, pacemakers, mechanic heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body.
- Previous CPAP treatment.
- Psycho-physical inability to complete questionnaires. Inadequate visual and auditory acuity will be excluded.
- Presence of any previously diagnosed sleep disorders: narcolepsy, insomnia, chronic sleep deprivation, REM behavior disorder and restless leg syndrome.
- Patients with > 50% of central apneas or the presence of Cheyne-Stokes Respiration.
- History of alcohol abuse or dependence.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: CPAP
Patients with CPAP treatment. Titration will be performed by polysomnography or automatic CPAP to determine the optimal treatment pressure. This group will also be instructed in hygienic-dietary measures and sleep hygiene counselling. |
CPAP treatment every night plus standard care for OSA: lifestyle, and sleep hygiene counselling
sleep higiene and dietary counseling
|
|
Comparador Ativo: Standard care for OSA
Sleep hygiene ( regular sleep schedule, avoid sedative drugs, alcohol and tobacco, physical exercise) and dietary counselling
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sleep higiene and dietary counseling
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Structural and functional brain changes
Prazo: at baseline and after 3 months of treatment
|
at baseline and after 3 months of treatment
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Assessment of the changing of the neuropsychological tests.
Prazo: at baseline and after 3 months of treatment
|
at baseline and after 3 months of treatment
|
|
OSA symptoms (daytime sleepiness and everyday function) and quality of life
Prazo: at baseline and after 3 months of treatment
|
at baseline and after 3 months of treatment
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Josep M Montserrat, MD, Spanish Research Center for Respiratory Diseases
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- OSA-E1
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