Ondine SyndromeVENTIPSYNCT03095729
Cognitive Consequences of an Activation of the Cortical Drive to Breath (VENTIPSY)
An observational study of Ondine Syndrome and Healthy, run by Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil at 1 site in France.
Trial summary
The purpose of the study is to measure the negative cognitive consequences of the ventilation under pathological or experimental cortical drive to breath. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ondine Syndrome, Healthy, Amyotrophic Lateral Sclerosis
- What is being tested?
- Neuropsychological tests
- How many people
- 65 participants
- Where
- 1 siteFrance
- Study dates
- 26 Apr 2017to 4 Jul 2019
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients and healthy volunteers
Who may be able to join
- Adults and non-vulnerable adults
- Fluent in French
Who cannot join
- For patients:
- Total ventilatory dependency
- Coexistence of an other respiratory disease
- Alcohol and /or psychotropic consumption during the last 24 hours
- One or more episodes of acute respiratory failure during the past 6 months
- Serious cognitive deficiency or presence of fronto temporal dementia
Show all 15Show fewer
- End-stage disease
- No affiliation to social security
- For healthy volunteers:
- Existing respiratory disease
- Alcohol and /or psychotropes consumption during the last 24 hours
- Tobacco smoking more than 2 pack-years
- Sleep deprivation
- Serious cognitive deficiency
- No affiliation to social security
Trial locations and contacts
1 site in 1 country.
France1 site
INSERM-UPC UMR_S 1158, Service de Pneumologie et Réanimation, GH Pitié-Salpêtrière
Paris, 75013
About this study
Official title: Cognitive Consequences of an Activation of the Cortical Drive to Breath
The purpose of the study is to measure the negative cognitive consequences of the ventilation under pathological or experimental cortical drive to breath.
Read the detailed description
Cognitive capacities are measured on healthy subject submitted to inspiratory threshold loading, patients treated by chronic mechanical ventilation due to suffering Ondine syndrome or amyotrophic lateral sclerosis. The spontaneous breathing is compared to NIV breathing or inspiratory threshold loading.
- Conditions
- Ondine Syndrome, Healthy, Amyotrophic Lateral Sclerosis
- Being tested
- Neuropsychological tests
- Medical subject headings
- Sleep Apnea, Central, Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological testsOther
A battery of tests to evaluate the overall cognitive performance of the subjects (memory, executive, attentional or instrumental functions)
| Study group | Role | What they receive |
|---|---|---|
| Healthy | 40 healthy subjects, during quiet breathing and under an inspiratory load (inspiratory threshold loading) Receives: Other: Neuropsychological tests | |
| Ondine syndrome | 12 patients presenting with central hypoventilation syndrome or Ondine's curse syndrome, during spontaneous breathing and with Non Invasive Ventilation Receives: Other: Neuropsychological tests | |
| Amyotrophic Lateral Sclerosis | 30 patients presenting with Amyotrophic Lateral Sclerosis during spontaneous breathing and with Non Invasive Ventilation Receives: Other: Neuropsychological tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score at PASAT (Paced Auditory Serial Addition Test)
Performances will be assessed by counting the number of good and wrong answers, and comparing it in two conditions : spontaneous breathing (SB) versus inspiratory resistive loading for healthy subjects, and SB versus non invasive ventilation for patients.
Measured: 3 hours
Secondary outcomes (1)
Oxygen saturation changes
Modifications of oxygen saturation measured using a saturometer placed on the subject's finger.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2017
- Study start26 Apr 2017
- Primary completion4 Jul 2019
- Study completion4 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ondine SyndromeStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
- Sponsor type
- University, hospital or other
- Collaborators
- Association Française du Syndrome d'Ondine, Fonds de Recherche en Santé Respiratoire
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03095729
- Sponsor's protocol ID
- ADOREPS_2017_9
- Acronym
- VENTIPSY
- Status last verified
- Jul 2021
- First submitted
- 9 Mar 2017
- Last updated
- 9 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Consequences of an Activation of the Cortical Drive to Breath
- ClinicalTrials.gov ID
- NCT03095729
- Acronym / sponsor ID
- VENTIPSY / ADOREPS_2017_9
- Conditions
- Ondine Syndrome, Healthy, Amyotrophic Lateral Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le SommeilUniversity, hospital or other
- Collaborators
- Association Française du Syndrome d'Ondine, Fonds de Recherche en Santé Respiratoire
- Study start
- 26 Apr 2017 (actual)
- Primary completion
- 4 Jul 2019 (actual)
- Study completion
- 4 Jul 2019 (actual)
- First posted
- 30 Mar 2017 (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.
The purpose of the study is to measure the negative cognitive consequences of the ventilation under pathological or experimental cortical drive to breath.
Detailed description
Cognitive capacities are measured on healthy subject submitted to inspiratory threshold loading, patients treated by chronic mechanical ventilation due to suffering Ondine syndrome or amyotrophic lateral sclerosis. The spontaneous breathing is compared to NIV breathing or inspiratory threshold loading.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | Other: Neuropsychological tests40 healthy subjects, during quiet breathing and under an inspiratory load (inspiratory threshold loading) |
| Ondine syndrome | – | Other: Neuropsychological tests12 patients presenting with central hypoventilation syndrome or Ondine's curse syndrome, during spontaneous breathing and with Non Invasive Ventilation |
| Amyotrophic Lateral Sclerosis | – | Other: Neuropsychological tests30 patients presenting with Amyotrophic Lateral Sclerosis during spontaneous breathing and with Non Invasive Ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients and healthy volunteers
Key inclusion criteria (2 listed)
- Adults and non-vulnerable adults
- Fluent in French
Key exclusion criteria (15 listed)
- Total ventilatory dependency
- Coexistence of an other respiratory disease
- Alcohol and /or psychotropic consumption during the last 24 hours
- One or more episodes of acute respiratory failure during the past 6 months
- Serious cognitive deficiency or presence of fronto temporal dementia
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 |
|---|---|---|
| Neuropsychological testsA battery of tests to evaluate the overall cognitive performance of the subjects (memory, executive, attentional or instrumental functions) | Other | Amyotrophic Lateral Sclerosis, Healthy, Ondine syndrome |
Primary outcome
Score at PASAT (Paced Auditory Serial Addition Test)
Time frame: 3 hours
Performances will be assessed by counting the number of good and wrong answers, and comparing it in two conditions : spontaneous breathing (SB) versus inspiratory resistive loading for healthy subjects, and SB versus non invasive ventilation for patients.
1 secondary outcome
Oxygen saturation changes
Time frame: 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2021.
Related trials for Ondine Syndrome
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Not yet recruitingObservational study
Registry of Central Sleep Apnea Patients Undergoing remedē System Implant
Central Sleep Apnea (Diagnosis), Central Sleep Apnea Syndrome
RecruitingPhase 4
Central Apnea in Heart Failure: Physiological Mechanisms to Inform Treatment
Sleep Disordered Breathing, Able Bodied
RecruitingObservational study
PAH-SDB: Sleep-Disordered Breathing and Outcomes in Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension (PAH), Sleep-disordered Breathing (SDB)
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ondine Syndrome and Healthy, run by Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil 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 2 inclusion and 15 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: finished, as of the sponsor's last update on 9 Jul 2021. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Score at PASAT (Paced Auditory Serial Addition Test) (time frame: 3 hours). 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 9 Jul 2021.