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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Catalonia
-
Barcelona, Catalonia, Spanien, 08036
- Hospital Clinic Barcelona
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
|
|
Aktiv komparator: Standard care for OSA
Sleep hygiene ( regular sleep schedule, avoid sedative drugs, alcohol and tobacco, physical exercise) and dietary counselling
|
sleep higiene and dietary counseling
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Structural and functional brain changes
Tidsram: at baseline and after 3 months of treatment
|
at baseline and after 3 months of treatment
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Assessment of the changing of the neuropsychological tests.
Tidsram: 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
Tidsram: at baseline and after 3 months of treatment
|
at baseline and after 3 months of treatment
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Josep M Montserrat, MD, Spanish Research Center for Respiratory Diseases
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- OSA-E1
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .