Obstructive Sleep ApneaNCT04198493
Effect of CPAP Treatment in Cognition in Adults With DS and OSA
A study testing CPAP and CONSERVATIVE TREATMENT for OSA in people with Obstructive Sleep Apnea, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
Adults with Down syndrome (DS) have a high prevalence of obstructive sleep apnea (OSA), which may worsen cognitive performance. In general population, continuous positive airway pressure (CPAP), the gold Standard treatment for OSA, partially reverses cognitive impairment secondary to OSA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- CPAP and CONSERVATIVE TREATMENT for OSA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2019to Nov 2021
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects of both sexes with ages over 18 years old with DS.
- A good general health with adequate visual and auditory acuity will be required
- Understanding and accepting the study procedures and signing an informed consent (guardian and / or patient).
- intelligence quotient(IQ) ratio> 34 (mild and moderate severe intellectual disability according to the International Statistical Classification of Diseases and Related Health Problems, ICD-10, criteria).
- Subjects without dementia: Absence of loss of cognitive functions (demonstrated by the longitudinal administration of neuropsychological tests and verified by family members)
- Absence of psychiatric comorbidity
Who cannot join
- Severe intellectual disability (due to limitations in cognitive tests)
- Presence of psychiatric pathology, unstable disease, cardiac or respiratory failure.
- Intake of psychoactive drugs in the three months prior to the study.
- Patients diagnosed with OSA, undergoing treatment with CPAP.
- Subjects with an Epworth Sleep Scale score > 12
Trial locations and contacts
1 site in 1 country.
Spain1 site
Multidisciplinary Sleep Unit. Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Sandra Gimenez, MD, PhD, +34935537324, sgimenez@santpau.cat
About this study
Official title: Impact of Continuous Positive Airway Pressure Treatment on Cognitive Function in Adults With Down Syndrome With Obstructive Sleep Apnea
Adults with Down syndrome (DS) have a high prevalence of obstructive sleep apnea (OSA), which may worsen cognitive performance.
In general population, continuous positive airway pressure (CPAP), the gold Standard treatment for OSA, partially reverses cognitive impairment secondary to OSA. CPAP treatment, however, is not regularly proposed in adults with DS and OSA. It is usually presumed both by caregivers and physicians, that DS patients will not tolerate or adapt to the treatment, and that they would not benefit much more from CPAP treatment. Therefore, data about the feasibility and impact of CPAP treatment on cognitive function in this population is lacking.
The main objective of this study is to investigate cognitive performance in adults with DS and OSA, the corresponding functional brain changes and their reversibility with CPAP treatment.
Read the detailed description
Population Participants will be included from the Catalan Down Syndrome Foundation (FCSD). After obtaining a written informed consent, approved by the ethical committee, a total of 60 adult subjects of both sexes with SD and without dementia will be included. Forty subjects with a diagnosis of severe OSA (AHI> 30) without significant comorbidities or excessive daytime sleepiness (Epworth <12) and 20 subjects without OSA.
Objectives:
The general objective is to evaluate cognitive and/or behavioural dysfunction in adults with Down syndrome that can improve with CPAP treatment.
- By evaluating sleep, cognitive function and behaviour aspects in adults with Down syndrome with and without OSA.
- By assessing the changes in sleep, in cognitive, behavioural function, and brain connectivity measures after 6 month of treatment in subjects with DS and severe OSA.
Secondary objectives:
- Assess the relationship between the severity of OSA (AHI, hypoxemia, sleep fragmentation) and severity in cognitive impairment.
- Identify possible sleep and anthropometric parameters that could suggest a worsening in cognitive function in subjects with DS and OSA.
Methodology:
Open pilot study with randomized therapeutic intervention of parallel groups and blind evaluation in neuropsychological assessment.
Patients with severe OSA will be randomized to i) conservative treatment (CT) or to ii) CPAP and conservative treatment.
Patients included in the study will be monitored and followed for 6 months. Patients with severe OSA will perform follow up visits to monitor the objective compliance and side effects of the treatment in the 1st, 3rd and 6th month.
At baseline and after 6 months of treatment, in the three groups of subjects (i) Subjects without OSA, ii) Subjects with OSA and CPAP treatment, and iii) Subjects with OSA+ TC treatment , it will be performed:
- Sleep evaluation: Subjective sleep quality (Pittsburgh sleep quality index) and daytime Somnolence (Epworth Sleepiness Scale) Nocturnal sleep by polysomnography (PSG) Sleep-wake pattern by actigraphy
- Neurocognitive function with an extensive neuropsychological battery assessing mainly memory, attention and executive functions for DS population. (CAMCOG-DS, Cued Recall Test (CRT), different subtests of the Barcelona Test battery: orientation in person, time and space, language items (comprehension, reading and writing), verbal abstraction and oculomotor praxis, cats and dogs test, Attention cancellation test, verbal fluency test.
- Measures of cerebral functional connectivity: through measures of consistency, mutual information, probability of synchronization and transfer entropy.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- CPAP, CONSERVATIVE TREATMENT for OSA
- Keywords
- Down Syndrome, Polysomnography
- Medical subject headings
- Sleep Apnea, Obstructive, Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
CPAP treatment every night plus conservative treatment for OSA: sleep hygiene and dietary counseling
CONSERVATIVE TREATMENT for OSAOther
Conservative treatment for OSA: sleep hygiene and dietary counseling
| Study group | Role | What they receive |
|---|---|---|
| Continuous Positive Airway Pressure(CPAP) | Experimental | Patients with CPAP treatment. Titration will be performed by polysomnography CPAP to determine the optimal treatment pressure.
This group will also be instructed in sleep hygiene and dietary counseling
Intervention:
Device: CPAP Other: Conservative treatment for OSA Receives: Device: CPAP; Other: CONSERVATIVE TREATMENT for OSA |
| CONSERVATIVE TREATMENT for OSA | Active comparator | Sleep hygiene and dietary counseling. Sleep hygiene (regular sleep schedule, physical exercise) and dietary counseling Intervention: Other: Conservative treatment for OSA Receives: Other: CONSERVATIVE TREATMENT for OSA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the changes on cognitive attentional tasks
psychomotor speed (in seconds) performing an attentional task
Measured: Baseline and after 6 months of treatment
Changes in cerebral functional connectivity
Significant probability maps (SPM) showing statistical changes on connectivity measures between sleep stages
Measured: Baseline and after 6 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study startDec 2019 (estimated)
- Primary completionNov 2020 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open pilot study with randomized therapeutic intervention of parallel groups and blind evaluation in neuropsychological assessment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04198493
- Sponsor's protocol ID
- IIBSP-SAH-2019-62
- Status last verified
- Dec 2019
- First submitted
- 28 Nov 2019
- Last updated
- 17 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Continuous Positive Airway Pressure Treatment on Cognitive Function in Adults With Down Syndrome With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT04198493
- Acronym / sponsor ID
- IIBSP-SAH-2019-62
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Down Syndrome, Polysomnography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- Dec 2019 (estimated)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 13 Dec 2019 (actual)
- 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.
Adults with Down syndrome (DS) have a high prevalence of obstructive sleep apnea (OSA), which may worsen cognitive performance.
In general population, continuous positive airway pressure (CPAP), the gold Standard treatment for OSA, partially reverses cognitive impairment secondary to OSA. CPAP treatment, however, is not regularly proposed in adults with DS and OSA. It is usually presumed both by caregivers and physicians, that DS patients will not tolerate or adapt to the treatment, and that they would not benefit much more from CPAP treatment. Therefore, data about the feasibility and impact of CPAP treatment on cognitive function in this population is lacking.
The main objective of this study is to investigate cognitive performance in adults with DS and OSA, the corresponding functional brain changes and their reversibility with CPAP treatment.
Detailed description
Population Participants will be included from the Catalan Down Syndrome Foundation (FCSD). After obtaining a written informed consent, approved by the ethical committee, a total of 60 adult subjects of both sexes with SD and without dementia will be included. Forty subjects with a diagnosis of severe OSA (AHI> 30) without significant comorbidities or excessive daytime sleepiness (Epworth <12) and 20 subjects without OSA.
Objectives:
The general objective is to evaluate cognitive and/or behavioural dysfunction in adults with Down syndrome that can improve with CPAP treatment.
- By evaluating sleep, cognitive function and behaviour aspects in adults with Down syndrome with and without OSA.
- By assessing the changes in sleep, in cognitive, behavioural function, and brain connectivity measures after 6 month of treatment in subjects with DS and severe OSA.
Secondary objectives:
- Assess the relationship between the severity of OSA (AHI, hypoxemia, sleep fragmentation) and severity in cognitive impairment.
- Identify possible sleep and anthropometric parameters that could suggest a worsening in cognitive function in subjects with DS and OSA.
Methodology:
Open pilot study with randomized therapeutic intervention of parallel groups and blind evaluation in neuropsychological assessment.
Patients with severe OSA will be randomized to i) conservative treatment (CT) or to ii) CPAP and conservative treatment.
Patients included in the study will be monitored and followed for 6 months. Patients with severe OSA will perform follow up visits to monitor the objective compliance and side effects of the treatment in the 1st, 3rd and 6th month.
At baseline and after 6 months of treatment, in the three groups of subjects (i) Subjects without OSA, ii) Subjects with OSA and CPAP treatment, and iii) Subjects with OSA+ TC treatment , it will be performed:
- Sleep evaluation: Subjective sleep quality (Pittsburgh sleep quality index) and daytime Somnolence (Epworth Sleepiness Scale) Nocturnal sleep by polysomnography (PSG) Sleep-wake pattern by actigraphy
- Neurocognitive function with an extensive neuropsychological battery assessing mainly memory, attention and executive functions for DS population. (CAMCOG-DS, Cued Recall Test (CRT), different subtests of the Barcelona Test battery: orientation in person, time and space, language items (comprehension, reading and writing), verbal abstraction and oculomotor praxis, cats and dogs test, Attention cancellation test, verbal fluency test.
- Measures of cerebral functional connectivity: through measures of consistency, mutual information, probability of synchronization and transfer entropy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Open pilot study with randomized therapeutic intervention of parallel groups and blind evaluation in neuropsychological assessment.
| Arm | Type | Receives |
|---|---|---|
| Continuous Positive Airway Pressure(CPAP) | Experimental | Device: CPAP, Other: CONSERVATIVE TREATMENT for OSAPatients with CPAP treatment. Titration will be performed by polysomnography CPAP to determine the optimal treatment pressure. This group will also be instructed in sleep hygiene and dietary counseling Intervention: Device: CPAP Other: Conservative treatment for OSA |
| CONSERVATIVE TREATMENT for OSA | Active comparator | Other: CONSERVATIVE TREATMENT for OSASleep hygiene and dietary counseling. Sleep hygiene (regular sleep schedule, physical exercise) and dietary counseling Intervention: Other: Conservative treatment for OSA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects of both sexes with ages over 18 years old with DS.
- A good general health with adequate visual and auditory acuity will be required
- Understanding and accepting the study procedures and signing an informed consent (guardian and / or patient).
- intelligence quotient(IQ) ratio> 34 (mild and moderate severe intellectual disability according to the International Statistical Classification of Diseases and Related Health Problems, ICD-10, criteria).
- Subjects without dementia: Absence of loss of cognitive functions (demonstrated by the longitudinal administration of neuropsychological tests and verified by family members)
Key exclusion criteria (5 listed)
- Severe intellectual disability (due to limitations in cognitive tests)
- Presence of psychiatric pathology, unstable disease, cardiac or respiratory failure.
- Intake of psychoactive drugs in the three months prior to the study.
- Patients diagnosed with OSA, undergoing treatment with CPAP.
- Subjects with an Epworth Sleep Scale score > 12
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 |
|---|---|---|
| CPAPCPAP treatment every night plus conservative treatment for OSA: sleep hygiene and dietary counseling | Device | Continuous Positive Airway Pressure(CPAP) |
| CONSERVATIVE TREATMENT for OSAConservative treatment for OSA: sleep hygiene and dietary counseling | Other | CONSERVATIVE TREATMENT for OSA, Continuous Positive Airway Pressure(CPAP) |
Primary outcome
Assessment of the changes on cognitive attentional tasks
Time frame: Baseline and after 6 months of treatment
psychomotor speed (in seconds) performing an attentional task
Changes in cerebral functional connectivity
Time frame: Baseline and after 6 months of treatment
Significant probability maps (SPM) showing statistical changes on connectivity measures between sleep stages
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP and CONSERVATIVE TREATMENT for OSA in people with Obstructive Sleep Apnea, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 17 Dec 2019. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SANDRA GIMENEZ BADIA, MD, PhD (+34935537855, sgimenez@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the changes on cognitive attentional tasks (time frame: Baseline and after 6 months of treatment). The study lists 2 primary outcomes in all. 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 17 Dec 2019.