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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Catalonia
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Barcelona, Catalonia, 스페인, 08036
- Hospital Clinic Barcelona
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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
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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Structural and functional brain changes
기간: at baseline and after 3 months of treatment
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at baseline and after 3 months of treatment
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Assessment of the changing of the neuropsychological tests.
기간: at baseline and after 3 months of treatment
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at baseline and after 3 months of treatment
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OSA symptoms (daytime sleepiness and everyday function) and quality of life
기간: at baseline and after 3 months of treatment
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at baseline and after 3 months of treatment
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공동 작업자 및 조사자
수사관
- 수석 연구원: Josep M Montserrat, MD, Spanish Research Center for Respiratory Diseases
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- OSA-E1
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