NCT02356666

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
232

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 5, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

February 26, 2016

Status Verified

February 1, 2016

Enrollment Period

11 months

First QC Date

December 17, 2014

Last Update Submit

February 25, 2016

Conditions

Neuromuscular Disease

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline (Day 1)

Secondary Outcomes (3)

  • Concordance between the diagnostic criteria

    Baseline (Day 1)

  • sensibility/specificity of the different criteria to identify daytime alveolar hypoventilation (defined on blood gas analysis)

    Baseine (Day 1)

  • Prognostic value of the different definitions of nocturnal hypoventilation

    5 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Neuromuscular disease

You may qualify if:

  • Neuromuscular disease
  • Age ≥18 years
  • Non mechanically ventilated

You may not qualify if:

  • Long-term oxygen therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Raymond Poincare

Garches, Garches, 92380, France

Location

MeSH Terms

Conditions

Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Officials

  • Adam Ogna, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2014

First Posted

February 5, 2015

Study Start

December 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

February 26, 2016

Record last verified: 2016-02

Locations

FR(1)