Ignite Creation Date:
2024-05-06 @ 8:50 AM
Last Modification Date:
2024-10-26 @ 12:05 PM
Study NCT ID:
NCT02833168
Status:
UNKNOWN
Last Update Posted:
2016-07-14
First Post:
2016-07-12
Brief Title:
Screening Questionnaire for Respiratory Muscle Weakness and Sleep-disordered Breathing in Neuromuscular Disorders
Sponsor:
Universität Münster
Organization:
Universität Münster
Study Overview
Official Title:
Validation of a German Language Screening Questionnaire for Symptoms of Respiratory Muscle Weakness and Sleep-disordered Breathing in Patients With Neuromuscular Disorders
Status:
UNKNOWN
Status Verified Date:
2016-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
SDB is a promiment clinical feature of various neuromuscular disorders including amyotrophic lateral sclerosis ALS spinal muscular atrophy SMA and myopathies such as myotonic dystrophy type 1 Pompe disease and limb-girdle muscular dystrophies LGMD In ALS SMA LGMD and Pompe disease SDB is usually caused by nocturnal alveolar hypoventilaton due to diaphragmatic weakness which manifests first during sleep and REM sleep in particular SDB usually leads to sleep disruption non-restorative sleep and daytime symptoms including morning headache hypersomnolence and increased neuromuscular fatigue In patients with severe diaphragmatic involvement both symptoms of SDB and potential complications of respiratory muscle weakness substantially add to overall disease burden of the disease and decrease life span Diagnosis of SDB is established by means of sleep studies which should ideally comprise polysomnography PSG and transcutaneous capnography PSG with capnometry is time-consuming expensive and not readily available for patients or referring physicians respectively For this reason it is desirable to thoroughly screen patients with neuromuscular disease for symptoms of SDB and respiratory muscle weakness Results from a validated screening questionnaire could be used as an adjunctive to pulmonary function testing or spirometry results in order to identify patients in whom sleep studies should be performed In addition a screening questionnaire would facilitate early recognition of patients with SDB enabling treating physicians to take appropriate steps to establish the diagnosis and to initiate non-invasive ventilation as early as possible
Until now there is no validated German language screening questionnaire for symptoms of respiratory muscle weakness and SDB Steier et al published an English language questionnaire which was validated as a screening tool in 33 patients with very different neuromuscular disorders which were predominantly neurogenic Steier et al 2011 In this study SDB was defined by an apnea hypopnea index above 5 per hour Nocturnal oxygen saturation and CO2 monitoring were not taken into account at all In addition the questionnaire does not systematically cover sleep-related symptoms of SDB in detail such as sleep disruption and morning headache which have to be separated from daytime symptoms such as dyspnea or orthopnea respectively
Thus the current project aims to correlate comprehensively generated items of a screening questionnaire with sleep study results including capnography alongside with respiratory muscle testing in patients with neuromuscular disorders As control subjects patients with newly diagnosed obstructive sleep apnea syndrome and sleep disorders other than sleep-related breathing disorders are enrolled in the study
Until now there is no validated German language screening questionnaire for symptoms of respiratory muscle weakness and SDB Steier et al published an English language questionnaire which was validated as a screening tool in 33 patients with very different neuromuscular disorders which were predominantly neurogenic Steier et al 2011 In this study SDB was defined by an apnea hypopnea index above 5 per hour Nocturnal oxygen saturation and CO2 monitoring were not taken into account at all In addition the questionnaire does not systematically cover sleep-related symptoms of SDB in detail such as sleep disruption and morning headache which have to be separated from daytime symptoms such as dyspnea or orthopnea respectively
Thus the current project aims to correlate comprehensively generated items of a screening questionnaire with sleep study results including capnography alongside with respiratory muscle testing in patients with neuromuscular disorders As control subjects patients with newly diagnosed obstructive sleep apnea syndrome and sleep disorders other than sleep-related breathing disorders are enrolled in the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None