Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01826032
Recruitment Status : Completed
First Posted : April 8, 2013
Last Update Posted : January 22, 2015
Sponsor:
Information provided by (Responsible Party):
Jose M. Montserrat, Hospital Clinic of Barcelona

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.


Condition or disease Intervention/treatment Phase
Sleep Apnea Device: CPAP Other: Standard care for OSA Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Obstructive Sleep Apneas in Elderly:Neuroimaging Changes and Neurocognitive Function Before and After Treatment
Study Start Date : November 2011
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: 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.

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

Active Comparator: Standard care for OSA
Sleep hygiene ( regular sleep schedule, avoid sedative drugs, alcohol and tobacco, physical exercise) and dietary counselling
Other: Standard care for OSA
sleep higiene and dietary counseling




Primary Outcome Measures :
  1. Structural and functional brain changes [ Time Frame: at baseline and after 3 months of treatment ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01826032


Locations
Layout table for location information
Spain
Hospital Clinic Barcelona
Barcelona, Catalonia, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
Layout table for investigator information
Principal Investigator: Josep M Montserrat, MD Spanish Research Center for Respiratory Diseases
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Jose M. Montserrat, MD, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT01826032    
Other Study ID Numbers: OSA-E1
First Posted: April 8, 2013    Key Record Dates
Last Update Posted: January 22, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases