Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine whether ambulatory polygraphy during a short hospitalization in a neurology unit has the same performance than inpatient polysomnography, the actual gold standard, in the diagnosis of sleep apnea in patients suffering from multiple system atrophy (MSA).
MSA patients frequently show sleep apnea. Inpatient polysomnography is currently the gold standard in the diagnosis of sleep apnea. However, its limited availability and high costs restrain a systematic screening of MSA patients. In contrast, ambulatory polygraphy is easy to achieve during a short hospitalization in a neurology unit or at the patient's home. Its validity in MSA is unknown.
The purpose of this study is to assess whether ambulatory polygraphy realized during a short hospitalization in a neurology unit has the same performance than inpatient polysomnography in the diagnosis of sleep apnea in MSA patients. Polygraphy recordings will also be done during daytime to characterize diurnal respiratory disturbances.
Principal Objective :
To assess the performance of ambulatory polygraphy in the diagnosis of sleep apnea in MSA patients in comparison to polysomnography (reference test).
Secondary Objectives :
To assess the performance of ambulatory polygraphy in the diagnosis of sleep apnea in comparison to polysomnography in two subgroups of MSA patients: one at high risk and one at low risk according to the results of the Berlin Questionnaire and the Epworth Sleepiness Scale.
To assess the inter-rater agreement of ambulatory polygraphy. To assess the association between sleep apnea and (i) the severity of MSA, (ii) the quality of life, (iii) the quality of sleep, and (iv) the presence of depression.
To assess the association between the severity of sleep apnea and (i) the severity of MSA, (ii) the quality of life, (iii) the quality of sleep and (iv) the presence of depression.
To assess diurnal respiratory disturbances in MSA by performing polygraphical recordings during daytime.
To assess the association of diurnal respiratory disturbances in MSA and (i) the severity of MSA and (ii) the quality of life.
Study design :
Cross-sectional prospective study (delay of one month between ambulatory polygraphy during a short hospitalization in a neurology unit and inpatient polysomnography). Each test will be carried out an interpreted blind to the other test.
Study plan:
Visit of Selection (V0)
Number of subjects :
30 patients (estimation of 15 patients at high risk of having sleep apnea and 15 patients at low risk).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polysomnography | Device | Simultaneous recording of electro-encephalography, tibial and submental electro-myography, electro-oculography, nasal air flow, oxygen saturation, as well as the thoracic and abdominal respiratory effort |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the performance of ambulatory polygraphy in the diagnosis of sleep apnea in comparison to polysomnography. Sensitivity, specificity, positive and negative predictive values, positive and negative likelihood ratios will be calculated. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the performance of ambulatory polygraphy in the diagnosis of sleep apnea in comparison to polysomnography in two subgroups (high vs low risk for sleep apnea). Performances of the tests will be compared between the two sub-groups. | 1 month | |
| Assessment of the performance of ambulatory polygraphy in the diagnosis of sleep apnea in comparison to polysomnography for different AHI thresholds (ROC curve analysis). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Wassilios Meissner, MD PhD | University Hospital Bordeaux, France | Principal Investigator |
| Paul PEREZ, MD, PhD | USMR, University Hospital, Bordeaux | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux - Hôpital Pellegrin | Bordeaux | 33096 | France | |||
| CHU de Bordeaux - Hôpital du Haut-Lévêque - Département de Neurologie - Centre de référence nationale maladie rare AMS |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24656908 | Result | Meissner WG, Flabeau O, Perez P, Taillard J, Marquant F, Dupouy S, Tison F, Philip P, Ghorayeb I. Accuracy of portable polygraphy for the diagnosis of sleep apnea in multiple system atrophy. Sleep Med. 2014 Apr;15(4):476-9. doi: 10.1016/j.sleep.2013.12.013. Epub 2014 Feb 21. | |
| 28011164 | Result | Flabeau O, Ghorayeb I, Perez P, Maillard A, Taillard J, Philip P, Foubert-Samier A, Tison F, Meissner WG. Impact of sleep apnea syndrome on survival in patients with multiple system atrophy. Parkinsonism Relat Disord. 2017 Feb;35:92-95. doi: 10.1016/j.parkreldis.2016.12.013. Epub 2016 Dec 16. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D019578 | Multiple System Atrophy |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
Not provided
Not provided
| ID | Term |
|---|---|
| D017286 | Polysomnography |
| ID | Term |
|---|---|
| D008991 | Monitoring, Physiologic |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ambulatory polygraphy | Device | Simultaneous recording of nasal air flow, oxygen saturation, as well as the abdominal and thoracic respiratory effort. |
|
| 1 month |
| Assessment of inter-rater variability by (i) calculating the intraclass correlation coefficient and its confidence interval (95%) for estimation of apnea/hypopnea index, and (ii) calculating kappa coefficient for SAOS diagnostic (dichotomous variable). | 1 month |
| Assessment of the association between sleep apnea and: severity of MSA (UMSARS), quality of life (MSA-Qol, SF-36), quality of sleep (PSQI) and depression (BDI). | 1 month |
| Assessment of the association between the severity of sleep apnea and: severity of MSA (UMSARS), quality of life (MSA-Qol, SF-36), quality of sleep (PSQI) and depression (BDI). | 1 month |
| Assessment of diurnal respiratory disturbances: 1. calculation of the AHI and the indices of obstructive and central respiratory events; description of all type of abnormal respiratory pattern. | 1 month |
| Assessment of the association between diurnal respiratory disturbances and: 1. the severity of MSA as measured by the UMSARS 2. the quality of life as measured by the MSA-QoL and SF-36 | 1 month |
| Pessac |
| 33604 |
| France |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |