Assessment of Ambulatory Polygraphy in the Detection of Sleep Apnea in Multiple System Atrophy (SAMSA)
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ClinicalTrials.gov Identifier: NCT00743561 |
Recruitment Status :
Completed
First Posted : August 29, 2008
Last Update Posted : April 30, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sleep Apnea Syndromes Multiple System Atrophy | Device: Polysomnography Device: ambulatory polygraphy | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Diagnostic |
Official Title: | Study of the Performance of Ambulatory Nocturnal Polygraphy in the Diagnosis of Sleep Apnea in Multiple System Atrophy |
Study Start Date : | June 2008 |
Actual Primary Completion Date : | December 2010 |
Actual Study Completion Date : | January 2011 |

Arm | Intervention/treatment |
---|---|
1 |
Device: Polysomnography
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 Device: ambulatory polygraphy Simultaneous recording of nasal air flow, oxygen saturation, as well as the abdominal and thoracic respiratory effort. |
- 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. [ Time Frame: 1 month ]
- 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. [ Time Frame: 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). [ Time Frame: 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). [ Time Frame: 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). [ Time Frame: 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). [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 1 month ]

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Ages Eligible for Study: | 30 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of "probable" MSA according to current consensus criteria (Gilman et al. 1999, PMID 10223419)
- Age 30-80 years
- Oral informed consent of patient or representative
- Patient requiring hospitalization in a neurology unit
Exclusion Criteria:
- Progressive cancer
- Significant cognitive impairment (MMSE<24)
- Sleep apnea
- Respiratory disorder
- Less than one year since previous polysomnography or ambulatory polygraphy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00743561
France | |
CHU de Bordeaux - Hôpital Pellegrin | |
Bordeaux, France, 33096 | |
CHU de Bordeaux - Hôpital du Haut-Lévêque - Département de Neurologie - Centre de référence nationale maladie rare AMS | |
Pessac, France, 33604 |
Principal Investigator: | Wassilios Meissner, MD PhD | University Hospital Bordeaux, France | |
Study Chair: | Paul PEREZ, MD, PhD | USMR, University Hospital, Bordeaux |
Responsible Party: | University Hospital, Bordeaux |
ClinicalTrials.gov Identifier: | NCT00743561 |
Other Study ID Numbers: |
CHUBX - 2007/04 |
First Posted: | August 29, 2008 Key Record Dates |
Last Update Posted: | April 30, 2012 |
Last Verified: | April 2012 |
MSA sleep apnea ambulatory polygraphy polysomnography |
Multiple System Atrophy Shy-Drager Syndrome Brain Diseases Apnea Sleep Apnea Syndromes Atrophy Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders |
Nervous System Diseases Pathological Conditions, Anatomical Primary Dysautonomias Autonomic Nervous System Diseases Basal Ganglia Diseases Central Nervous System Diseases Movement Disorders Neurodegenerative Diseases Hypotension Vascular Diseases Cardiovascular Diseases |