Obstructive Sleep Apneas in Elderly:Neuroimaging Changes and Neurocognitive Function Before and After Treatment

Sleep Apnea Clinical Trial

Official title:

Obstructive Sleep Apneas in Elderly:Neuroimaging Changes and Neurocognitive Function Before and After Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01826032
• Other study ID #: OSA-E1
• Status: Completed
• Phase: N/A
• First received: March 22, 2013
• Last updated: January 21, 2015
• Start date: November 2011
• Est. completion date: September 2014

Study information

• Verified date: January 2015
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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:

1. Neuroimaging by MRI

2. 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),

3. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

1. Men and women = 65 years old.

2. Patients diagnosed with OSA with an apnea-hypopnea index per hour >30.

3. Patients with an Epworth Sleep Scale score = 12 (without excessive daytime sleepiness).

4. Signed written informed consent.

Exclusion Criteria:

1. Patients with severe chronic diseases: cardiovascular or pulmonary, neurological (stroke, epilepsy, head injury...) or psychiatric.

2. 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.

3. Mini Mental State Exam (MMSE) <24.

4. Any MRI exclusions - presence of aneurysm clips, pacemakers, mechanic heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body.

5. Previous CPAP treatment.

6. Psycho-physical inability to complete questionnaires. Inadequate visual and auditory acuity will be excluded.

7. Presence of any previously diagnosed sleep disorders: narcolepsy, insomnia, chronic sleep deprivation, REM behavior disorder and restless leg syndrome.

8. Patients with > 50% of central apneas or the presence of Cheyne-Stokes Respiration.

9. History of alcohol abuse or dependence.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Other:
• Standard care for OSA
sleep higiene and dietary counseling

Locations

Country	Name	City	State
Spain	Hospital Clinic Barcelona	Barcelona	Catalonia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Structural and functional brain changes		at baseline and after 3 months of treatment	No
Secondary	Assessment of the changing of the neuropsychological tests.		at baseline and after 3 months of treatment	No
Secondary	OSA symptoms (daytime sleepiness and everyday function) and quality of life		at baseline and after 3 months of treatment	No