Neuromuscular DiseaseTcCO2NCT02356666
Prevalence of Nocturnal Hypoventilation in Neuromuscular Diseases According to Different Definitions
An observational study of Neuromuscular Disease, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
Trial summary
Different definitions of nocturnal hypoventilation are used in the recent literature. The investigators aimed to compare the prevalence of nocturnal hypoventilation in a neuromuscular disease's population according to different definitions issued from the literature. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromuscular Disease
- How many people
- 232 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2014to Nov 2015
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Neuromuscular disease
Who may be able to join
- Neuromuscular disease
- Age ≥18 years
- Non mechanically ventilated
Who cannot join
- Long-term oxygen therapy
Trial locations and contacts
1 site in 1 country.
About this study
Different definitions of nocturnal hypoventilation are used in the recent literature. The investigators aimed to compare the prevalence of nocturnal hypoventilation in a neuromuscular disease's population according to different definitions issued from the literature.
Read the detailed description
Different definitions of nocturnal hypoventilation are used in the recent literature. Basing on retrospective data review, we aimed to compare the prevalence of nocturnal hypoventilation in the cohort of neuromuscular disease's patients followed at our reference center, according to different definitions issued from the literature.
- Conditions
- Neuromuscular Disease
- Medical subject headings
- Neuromuscular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in the prevalence of nocturnal hypoventilation according to different previously proposed definitions
The prevalence of nocturnal hypoventilation (percentage of patients diagnosed as having hypoventilation over the total population) according to the different definition available in the literature will be described
Measured: Baseline (Day 1)
Secondary outcomes (3)
Concordance between the diagnostic criteria
Concordance between the different diagnostic criteria of hypoventilation
Measured: Baseline (Day 1)
sensibility/specificity of the different criteria to identify daytime alveolar hypoventilation (defined on blood gas analysis)
sensibility/specificity of the different criteria to identify daytime alveolar hypoventilation (defined on blood gas analysis)
Measured: Baseine (Day 1)
Prognostic value of the different definitions of nocturnal hypoventilation
The ability of the examined definition to predict the need for mechanical ventilation will be investigated, defined as appearance of daytime hypercapnia or beginning of mechanical ventilation and/or mortality.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2015 (estimated)
- Study startDec 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular DiseaseStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adam Ogna, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02356666
- Sponsor's protocol ID
- 1817118
- Acronym
- TcCO2
- Status last verified
- Feb 2016
- First submitted
- 17 Dec 2014
- Last updated
- 26 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Nocturnal Hypoventilation in Neuromuscular Diseases According to Different Definitions
- ClinicalTrials.gov ID
- NCT02356666
- Acronym / sponsor ID
- TcCO2 / 1817118
- Conditions
- Neuromuscular Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Study start
- Dec 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 5 Feb 2015 (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.
Different definitions of nocturnal hypoventilation are used in the recent literature. The investigators aimed to compare the prevalence of nocturnal hypoventilation in a neuromuscular disease's population according to different definitions issued from the literature.
Detailed description
Different definitions of nocturnal hypoventilation are used in the recent literature. Basing on retrospective data review, we aimed to compare the prevalence of nocturnal hypoventilation in the cohort of neuromuscular disease's patients followed at our reference center, according to different definitions issued from the literature.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Neuromuscular disease
Key inclusion criteria (3 listed)
- Neuromuscular disease
- Age ≥18 years
- Non mechanically ventilated
Key exclusion criteria (1 listed)
- Long-term oxygen therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Differences in the prevalence of nocturnal hypoventilation according to different previously proposed definitions
Time frame: Baseline (Day 1)
The prevalence of nocturnal hypoventilation (percentage of patients diagnosed as having hypoventilation over the total population) according to the different definition available in the literature will be described
3 secondary outcomes
Concordance between the diagnostic criteria
Time frame: Baseline (Day 1)
sensibility/specificity of the different criteria to identify daytime alveolar hypoventilation (defined on blood gas analysis)
Time frame: Baseine (Day 1)
Prognostic value of the different definitions of nocturnal hypoventilation
Time frame: 5 years
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 26 Feb 2016.
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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.
Adam Ogna, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
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 Neuromuscular Disease, run by Centre d'Investigation Clinique et Technologique 805 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 3 inclusion and 1 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 26 Feb 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 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?
Differences in the prevalence of nocturnal hypoventilation according to different previously proposed definitions (time frame: Baseline (Day 1)). 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 26 Feb 2016; AzTrials last refreshed its copy on 8 Nov 2026.