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

NCT ID: NCT01826032

Last Updated: 2015-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2014-09-30

Brief 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.

Detailed 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.

Conditions

Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

CPAP

Intervention Type: DEVICE

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

Standard care for OSA

Intervention Type: OTHER

sleep higiene and dietary counseling

Standard care for OSA

Sleep hygiene ( regular sleep schedule, avoid sedative drugs, alcohol and tobacco, physical exercise) and dietary counselling

Group Type: ACTIVE_COMPARATOR

Standard care for OSA

Intervention Type: OTHER

sleep higiene and dietary counseling

Interventions

CPAP

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

Intervention Type: DEVICE

Standard care for OSA

sleep higiene and dietary counseling

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Clinic of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Jose M. Montserrat

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Josep M Montserrat, MD

Role: PRINCIPAL_INVESTIGATOR

Spanish Research Center for Respiratory Diseases

Locations

Hospital Clinic Barcelona

Barcelona, Catalonia, Spain

Countries

Spain

References

Dalmases M, Sole-Padulles C, Torres M, Embid C, Nunez MD, Martinez-Garcia MA, Farre R, Bargallo N, Bartres-Faz D, Montserrat JM. Effect of CPAP on Cognition, Brain Function, and Structure Among Elderly Patients With OSA: A Randomized Pilot Study. Chest. 2015 Nov;148(5):1214-1223. doi: 10.1378/chest.15-0171.

Reference Type: DERIVED

PMID: 26065720 (View on PubMed)

Other Identifiers

OSA-E1

Identifier Type: -

Identifier Source: org_study_id