Early Onset Alzheimer DiseaseAZAPNCT01400542
Sleep Apnea in Early to Mid-Stage Alzheimer's Disease
An observational study of Early Onset Alzheimer Disease and Alzheimer Disease, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Early Onset Alzheimer Disease, Alzheimer Disease, Obstructive Sleep Apnea Syndromes
- What is being tested?
- CPAP Treatment and No treatment
- Type of treatment
- Medical device
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2010to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly patients with a early or mid-Stage Alzheimer's disease with or without SAOS.
Who may be able to join
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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?
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.
Read more
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.
Read the 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.
- Being tested
- CPAP Treatment, No treatment
- Keywords
- Early Onset Alzheimer Disease, Alzheimer Disease, Sleep Apnea Syndromes, Obstructive Sleep Apnea Syndromes, Cognitive functions, Continuous Positive Airway Pressure (CPAP) treatment
- Medical subject headings
- Alzheimer Disease, Sleep Apnea Syndromes, Microcephaly, Primary Autosomal Recessive, 6
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP TreatmentDevice
Also called The CPAP devices used are :, PPC ISLEEP 20 (Breas), PPC S8 AUTOSET SPIRIT II AUTO (Resmed), AUTOSET CS2 (Resmed)
Patients with obstructive sleep apnea syndrome will be treated by Continuous Positive Airway Pressure (CPAP) at home during all 4 months all nights.
No treatmentDevice
no treatment
| Study group | Role | What they receive |
|---|---|---|
| OSAS + | Patient with obstructive sleep apnea syndrome (OSAS)detected at the inclusion visit by a polysomnography Receives: Device: CPAP Treatment | |
| OSAS - | Patient without obstructive sleep apnea syndrome (OSAS)detected at the inclusion visit by a polysomnography Receives: Device: No treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of the CPAP treatment on cognitive functions
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.
Measured: At 4 Months
Secondary outcomes (3)
Rate of apnea/hypopnea events per hour (AHI/h)
This secondary outcome measure is only for the treated group by CPAP.
Measured: Each month from Day 1 to Month 4
Impact of CPAP treatment on neuropsychological evaluation parameters
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.
Measured: At 4 months
Impact of the CPAP treatment on Quality of Life
It measured by the QOL-AD questionnaire
Measured: At 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study startDec 2010
- Primary completionJun 2014
- Study completionJun 2014
Why it stopped: End of the study because of the inclusions were too difficult
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Onset Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Association Lyonnaise de Logistique Posthospitalière
- Responsible party
- Sponsor
- Investigators
- Emilie ACHOUR, MD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01400542
- Sponsor's protocol ID
- 1002050
- Other IDs
- 2010-A01003-36
- Acronym
- AZAP
- Status last verified
- Aug 2016
- First submitted
- 20 Jul 2011
- Last updated
- 11 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT01400542
- Acronym / sponsor ID
- AZAP / 1002050
- Keywords
- Early Onset Alzheimer Disease, Alzheimer Disease, Sleep Apnea Syndromes, Obstructive Sleep Apnea Syndromes, Cognitive functions, Continuous Positive Airway Pressure (CPAP) treatment
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: End of the study because of the inclusions were too difficult
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Association Lyonnaise de Logistique Posthospitalière
- Study start
- Dec 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 22 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OSAS + | – | Device: CPAP TreatmentPatient with obstructive sleep apnea syndrome (OSAS)detected at the inclusion visit by a polysomnography |
| OSAS - | – | Device: No treatmentPatient without obstructive sleep apnea syndrome (OSAS)detected at the inclusion visit by a polysomnography |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly patients with a early or mid-Stage Alzheimer's disease with or without SAOS.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAP TreatmentAlso: The CPAP devices used are :, PPC ISLEEP 20 (Breas), PPC S8 AUTOSET SPIRIT II AUTO (Resmed), AUTOSET CS2 (Resmed)Patients with obstructive sleep apnea syndrome will be treated by Continuous Positive Airway Pressure (CPAP) at home during all 4 months all nights. | Device | OSAS + |
| No treatmentno treatment | Device | OSAS - |
Primary outcome
Impact of the CPAP treatment on cognitive functions
Time frame: At 4 Months
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.
3 secondary outcomes
Rate of apnea/hypopnea events per hour (AHI/h)
Time frame: Each month from Day 1 to Month 4
Impact of CPAP treatment on neuropsychological evaluation parameters
Time frame: At 4 months
Impact of the CPAP treatment on Quality of Life
Time frame: At 4 months
Results and safety
The study was stopped early (reason given: End of the study because of the inclusions were too difficult). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emilie ACHOUR, MD principal investigator
CHU de Saint-Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Onset Alzheimer Disease and Alzheimer Disease, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: End of the study because of the inclusions were too difficult). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of the CPAP treatment on cognitive functions (time frame: At 4 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2016.