NCT02833168

Brief Summary

It is the aim of this project to develop and validate a German language screening questionnaire for symptoms of respiratory muscle weakness and sleep-disordered breathing (SDB) in patients with neuromuscular disorders.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2016

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 14, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

July 14, 2016

Status Verified

July 1, 2016

Enrollment Period

8 months

First QC Date

July 12, 2016

Last Update Submit

July 13, 2016

Conditions

Neuromuscular Disorders

Keywords

Neuromuscular disordersSleep disordered breathingDyspnea

Outcome Measures

Primary Outcomes (1)

  • Nocturnal hypercapnia tcCO2

    1 day

Study Arms (3)

1

Patients with proven neuromuscular disorders known to be potentially associated with significant diaphragmatic weakness, e. g. ALS, myotonic dystrophy type 1, limb-girdle muscular dystrophy, Duchenne and Becker muscular dystrophy. Patients already receiving home ventilatory support will not be included in the study.

Other: patient-filled questionnairesDevice: spiromanometry

2

Patient with proven obstructive sleep apnea syndrome prior to CPAP initiation.

Other: patient-filled questionnairesDevice: spiromanometry

3

Patients with sleep disorders other than sleep-related breathing disorders, e. g. narcolepsy, hypersomnia, parasomnia or sleep-related movement disorders.

Other: patient-filled questionnairesDevice: spiromanometry

Interventions

patient-filled questionnairesOTHER

All patients answer selected questionnaires on sleep-related symptoms, sleep quality, daytime performance, and health-related quality of life.

123
spiromanometryDEVICE

Measurement of forced vital capacity, maximum inspiratory pressure and maximum expiratory pressure

123

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with neuromuscular disorders, newly diagnosed obstructive sleep apnea syndrome or sleep disorders other than sleep-related breathing disorders (30 patients in each group)

You may qualify if:

  • proven neuromuscular disease known to be potentially associated with diaphragmatic weakness (group 1)
  • newly diagnosed obstructive sleep apnea with an apnea hypopnea index \> 15/h total sleep time (group 2)
  • newly diagnosed narcolepsy, hypersomnia, insomnia or parasomnia in the absence of any sleep-related breathing disorder (group 3)
  • availability of recent diagnostic sleep studies including polysomnography and transcutaneous capnography

You may not qualify if:

  • ongoing CPAP oder non-invasive ventilation
  • inability to participate in study procedures
  • severe lung disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital Münster, Department of Sleep Medicine and Neuromuscular Disorders

Münster, 48149, Germany

RECRUITING

Bethanien Hospital

Solingen, 42699, Germany

RECRUITING

MeSH Terms

Conditions

Neuromuscular DiseasesSleep Apnea SyndromesDyspnea

Condition Hierarchy (Ancestors)

Nervous System DiseasesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Matthias Boentert, MD

    University Hospital Münster, Department of Sleep Medicine and Neuromuscular Disorders

    STUDY CHAIR

Central Study Contacts

Matthias Boentert, MD

CONTACT

+49-251-83matthias.boentert@ukmuenster.de

Peter Young, MD

CONTACT

+49-251-83peter.young@ukmuenster.de

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Senior Consultant in Neurology and Sleep Medicine

Study Record Dates

First Submitted

July 12, 2016

First Posted

July 14, 2016

Study Start

April 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

July 14, 2016

Record last verified: 2016-07

Locations

DE(2)