Sleep Apnea in Early to Mid-Stage Alzheimer's Disease (AZAP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Centre Hospitalier Universitaire de Saint Etienne
Sponsor:
Collaborator:
Association Lyonnaise de Logistique Posthospitalière
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT01400542
First received: July 20, 2011
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

Obstructive sleep apnea (OSA) is much more common in the elderly than in the young; the latest studies show prevalence between 45% and 62% in individuals over 60. It is even higher in patients with dementia such as Alzheimer patients.

Several trials in elderly patients showed modified cognitive functions, particularly executive and attentional functions, in patients with respiratory sleep disorder. However the benefit of CPAP (Continuous Positive Airway Pressure) ventilation for Alzheimer patients is still controversial, as there are few studies documenting its effects on dementia patients' cognitive abilities, and clinicians appear reluctant to prescribe this type of treatment.

The investigators must keep in mind that Alzheimer patients suffer significant sleep disorders; advanced- stage patients spend 40% of the night awake and are drowsy a large part of the day. In dementia patients, sleep disorder is a major cause of hospitalization and institutionalization. The prevalence of obstructive sleep apnea (OSA) in this population is estimated at over 50%, and appears to be higher the more advanced the dementia. Trials on obstructive sleep apnea syndromes in Alzheimer patients show significatively improved scores on the apnea-hypopnea index (AHI), as well as satisfactory treatment tolerance. However, any impact on cognitive abilities has yet to be demonstrated.

In addition, cardiovascular pathologies such as arterial hypertension, cardiac arrhythmias, and strokes are strongly correlated to OSA. In light of its consequences on morbidity and mortality, OSA should be considered a public health issue.

In this context, the investigators wish to address the impact of CPAP treatment implementation on the cognitive parameters of patients diagnosed with OSA, particularly on their executive functions. This should provide evidence for mid-term assessment of the benefits of CPAP in caring for elderly patients with dementia.

In light of the prevalence of obstructive sleep pathologies in elderly patients reported in various studies and of the potential impact of CPAP treatment on cognitive abilities, the investigators propose a study to evaluate the impact of OSA treatment on elderly Alzheimer patients' cognitive abilities, particularly on their executive functions.

Executive functions are a rather heterogenous group of high-level cognitive processes which enable individuals to adopt a flexible, context-appropriate behavior. They also include planning abilities, working memory, cognitive control, abstract thought, rule learning, selective attention, motor response selection, etc... Executive functions are mainly associated to the functioning of the brain's frontal lobes, although subcortical structures also play a role. When the executive functions are affected by disease, daily life is significantly impeded as the individual becomes unable to perform complex tasks or regulate his/her behavior. Many tests can help evaluate these functions in dementia patients. A number of "ecological" tests, such as the zoo map test from the Behavioural Assessment of the Dysexecutive Syndrome (BADS) arsenal, are quite relevant for evaluating executive functions.

This project aims to improve the daily life of Alzheimer patients with sleep apnea by improving their executive cognitive functions through CPAP treatment.

According to the Paquid's trial, there are 12,400 Alzheimer patients in the French Loire department. [27] The study population will therefore be recruited in the "La Charité" center of CHU Saint-Etienne. The target population is older individuals (≥ 65) suffering from cognitive disorders similar to Alzheimer's disease.

OSA will be diagnosed based on polysomnography, on an outpatient basis. Apnea patients will receive CPAP treatment for 4 months, which is the minimum duration required to implement and accept treatment, and to measure its impact on patients' neurocognitive abilities.


Condition Intervention
Early Onset Alzheimer Disease
Alzheimer Disease
Obstructive Sleep Apnea Syndromes
Device: CPAP Treatment
Device: No treatment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sleep Apnea in Early to Mid-Stage Alzheimer's Disease: What Impact of Treatment on the Cognitive Functions of Elderly Patients With Memory Loss?

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • Impact of the CPAP treatment on cognitive functions [ Time Frame: At 4 Months ] [ Designated as safety issue: No ]
    BADS zoo map scores : subjects are tested in two experimental settings, formulation and execution. The total execution time is the time taken to perform the task assigned in both conditions; the error score measures mistakes made during the test.


Secondary Outcome Measures:
  • Rate of apnea/hypopnea events per hour (AHI/h) [ Time Frame: Each month from Day 1 to Month 4 ] [ Designated as safety issue: No ]
    This secondary outcome measure is only for the treated group by CPAP.

  • Impact of CPAP treatment on neuropsychological evaluation parameters [ Time Frame: At 4 months ] [ Designated as safety issue: No ]

    This impact is measured by theses following neuropsychological tests : MMS, clock drawing test, five-word test, Benton Visual Retention Test, Similarities Test (WAIS-R subtest), Coding test (WAIS-III subtest), digit and visual span tasks (forward and backward) from WAIS III, alphabetical and categorical verbal fluency tasks, part A and B of the Trail Making Test, and Stroop test.

    The consideration of these tests separately has no interest. The sum of these tests is important.


  • Impact of the CPAP treatment on Quality of Life [ Time Frame: At 4 months ] [ Designated as safety issue: No ]
    It measured by the QOL-AD questionnaire


Estimated Enrollment: 100
Study Start Date: December 2010
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
OSAS +
Patient with obstructive sleep apnea syndrome (OSAS)detected at the inclusion visit by a polysomnography
Device: CPAP Treatment
Patients with obstructive sleep apnea syndrome will be treated by Continuous Positive Airway Pressure (CPAP) at home during all 4 months all nights.
Other Names:
  • The CPAP devices used are :
  • PPC ISLEEP 20 (Breas)
  • PPC S8 AUTOSET SPIRIT II AUTO (Resmed)
  • AUTOSET CS2 (Resmed)
  • REMSTAR AUTO M.SERIES (Respironics)
  • REMSTAR PRO M?SERIES (Respironics)
  • PPC SYSTEM ONE AUTO A FLEX (Respironics)
  • PPC SOMNOSMART 2 (Weinmann)
OSAS -
Patient without obstructive sleep apnea syndrome (OSAS)detected at the inclusion visit by a polysomnography
Device: No treatment
no treatment

Detailed Description:

This study's originality lies in that the target population is elderly and has been diagnosed with both Alzheimer's disease and sleep apnea, and in that it focuses on the impact of treatment on these patient's cognitive abilities, particularly on their executive abilities.We aim to provide practitioners with evidence-based arguments for screening and treating sleep apnea in dementia patients in order to care for these patients, whose treatment options are often scarce.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Elderly patients with a early or mid-Stage Alzheimer's disease with or without SAOS.

Criteria

Inclusion Criteria:

  • Diagnosis of Alzheimer-type dementia confirmed by the study's memory specialist.
  • MMS comprised between 20 and 28 (inclusive)
  • One main caregiver with full mental capacity, living under the same roof, present at all medical visits
  • Patient covered by compulsory health insurance
  • Patient signed the informed consent form

Exclusion Criteria:

  • Prior diagnosis of sleep apnea or patients already benefitting from respiratory assistance equipment- History of COPD (Chronic Obstructive Pulmonary Disease), treated with bronchodilators or corticoids
  • Patients with severe heart failure (stages III and IV of the NYHA Functional Classification)
  • Patients with a recent history of stroke or myocardial infarction (within the last three months)
  • Recently initiated or modified anticholinergic treatment (within the last two months)
  • Patients under guardianship
  • Behavioral disorders (pacing, agitation)
  • Patients with severe dementia
  • Patient with potentially low tolerance to treatment (latex allergies, claustrophobia, prior CPAP treatment which was badly tolerated)
  • Serious bullous lung disease
  • Pneumothorax
  • Arterial hypotension
  • Dehydration
  • Cerebrospinal fluid effusion, recent concussion, or cranial surgery
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01400542

Contacts
Contact: Emilie ACHOUR, MD (0)4 77 12 70 49 ext +33 emilie.achour@chu-st-etienne.fr
Contact: Frederic ROCHE, MD PhD (0)4 77 82 83 00 ext +33 frederic.roche@univ-st-etienne.fr

Locations
France
CHU de Saint-Etienne Recruiting
Saint-etienne, France, 42000
Principal Investigator: Emilie ACHOUR, MD         
Sub-Investigator: Frédéric ROCHE, MD PhD         
Sub-Investigator: Régis GONTHIER, MD PhD         
Sub-Investigator: Chantal GIRTANNER, MD PhD         
Sub-Investigator: Catherine TERRAT, MD PhD         
Sub-Investigator: Denis FEDERICO, MD         
Sub-Investigator: Karine CASTRO-LIONARD, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Association Lyonnaise de Logistique Posthospitalière
Investigators
Principal Investigator: Emilie ACHOUR, MD CHU de Saint-Etienne
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT01400542     History of Changes
Other Study ID Numbers: 1002050, 2010-A01003-36
Study First Received: July 20, 2011
Last Updated: July 23, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: French Data Protection Authority

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Early Onset Alzheimer Disease
Alzheimer Disease
Sleep Apnea Syndromes
Obstructive Sleep Apnea Syndromes
Cognitive functions
Continuous Positive Airway Pressure (CPAP) treatment

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Alzheimer Disease
Apnea
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders

ClinicalTrials.gov processed this record on July 26, 2014