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

Primary Purpose

Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
CPAP
Standard care for OSA
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Clinic Barcelona

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CPAP

Standard care for OSA

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Structural and functional brain changes

Secondary Outcome Measures

Assessment of the changing of the neuropsychological tests.
OSA symptoms (daytime sleepiness and everyday function) and quality of life

Full Information

First Posted
March 22, 2013
Last Updated
January 21, 2015
Sponsor
Hospital Clinic of Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT01826032
Brief Title
Obstructive Sleep Apneas in Elderly:Neuroimaging Changes and Neurocognitive Function Before and After Treatment
Official Title
Obstructive Sleep Apneas in Elderly:Neuroimaging Changes and Neurocognitive Function Before and After Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CPAP
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard care for OSA
Arm Type
Active Comparator
Arm Description
Sleep hygiene ( regular sleep schedule, avoid sedative drugs, alcohol and tobacco, physical exercise) and dietary counselling
Intervention Type
Device
Intervention Name(s)
CPAP
Intervention Description
CPAP treatment every night plus standard care for OSA: lifestyle, and sleep hygiene counselling
Intervention Type
Other
Intervention Name(s)
Standard care for OSA
Intervention Description
sleep higiene and dietary counseling
Primary Outcome Measure Information:
Title
Structural and functional brain changes
Time Frame
at baseline and after 3 months of treatment
Secondary Outcome Measure Information:
Title
Assessment of the changing of the neuropsychological tests.
Time Frame
at baseline and after 3 months of treatment
Title
OSA symptoms (daytime sleepiness and everyday function) and quality of life
Time Frame
at baseline and after 3 months of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josep M Montserrat, MD
Organizational Affiliation
Spanish Research Center for Respiratory Diseases
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clinic Barcelona
City
Barcelona
State/Province
Catalonia
ZIP/Postal Code
08036
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
26065720
Citation
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.
Results Reference
derived

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

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