Skip to main content
OpenTrials
Completed

NCT Number: NCT01826032

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clinic Barcelona

Barcelona, Catalonia, 08036, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CPAP

Device

CPAP treatment every night plus standard care for OSA: lifestyle, and sleep hygiene counselling

Standard care for OSA

Other

sleep higiene and dietary counseling

Primary outcomes

  1. Structural and functional brain changes

    Time frame: at baseline and after 3 months of treatment

Secondary outcomes

  1. Assessment of the changing of the neuropsychological tests.

    Time frame: at baseline and after 3 months of treatment

  2. OSA symptoms (daytime sleepiness and everyday function) and quality of life

    Time frame: at baseline and after 3 months of treatment

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Apr 8, 2013
Registry last updated
Jan 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.