NCT01826032

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 8, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

January 22, 2015

Status Verified

January 1, 2015

Enrollment Period

2.8 years

First QC Date

March 22, 2013

Last Update Submit

January 21, 2015

Conditions

Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • Structural and functional brain changes

    at baseline and after 3 months of treatment

Secondary Outcomes (2)

  • Assessment of the changing of the neuropsychological tests.

    at baseline and after 3 months of treatment

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

    at baseline and after 3 months of treatment

Study Arms (2)

CPAP

EXPERIMENTAL

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: CPAPOther: Standard care for OSA

Standard care for OSA

ACTIVE COMPARATOR

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

Other: Standard care for OSA

Interventions

CPAPDEVICE

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

CPAP
Standard care for OSAOTHER

sleep higiene and dietary counseling

CPAPStandard care for OSA

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinic Barcelona

Barcelona, Catalonia, 08036, Spain

Location

Related Publications (1)

  • 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.

    PMID: 26065720DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Josep M Montserrat, MD

    Spanish Research Center for Respiratory Diseases

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 22, 2013

First Posted

April 8, 2013

Study Start

November 1, 2011

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

January 22, 2015

Record last verified: 2015-01

Locations

ES(1)