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

Sponsor:

Information provided by (Responsible Party):

University Hospital, Bordeaux

Study Description

Brief Summary:

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).

Condition or disease	Intervention/treatment	Phase
Sleep Apnea Syndromes Multiple System Atrophy	Device: Polysomnography Device: ambulatory polygraphy	Not Applicable

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Detailed Description:

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)

Verification of eligibility
Study related information Visit of inclusion (From 0 to 90 days after selection)
Verification of eligibility
Diagnosis criteria
Oral informed consent of patient or representative
Clinical examination by using UMSARS, MMSE, Berlin Questionnaire, Epworth Sleepiness Scale, PSQI, MSA-QoL, SF-36 and Beck Depression Inventory
Ambulatory polygraphy during a short hospitalization in a neurology unit Visit of follow-up (V2, 1 month ± 5 days after V1)
Clinical examination by using UMSARS, Berlin Questionnaire and Epworth Sleepiness Scale
Inpatient polysomnography

Number of subjects :

30 patients (estimation of 15 patients at high risk of having sleep apnea and 15 patients at low risk).

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	30 participants
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

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Multiple system atrophy

MedlinePlus related topics: Sleep Apnea

Genetic and Rare Diseases Information Center resources: Multiple System Atrophy

U.S. FDA Resources

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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 ]

Secondary Outcome Measures :

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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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

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

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

Locations

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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

Sponsors and Collaborators

University Hospital, Bordeaux

Investigators

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Principal Investigator:	Wassilios Meissner, MD PhD	University Hospital Bordeaux, France
Study Chair:	Paul PEREZ, MD, PhD	USMR, University Hospital, Bordeaux

More Information

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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

Keywords provided by University Hospital, Bordeaux:


MSA sleep apnea ambulatory polygraphy polysomnography

Additional relevant MeSH terms:

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Multiple System Atrophy Shy-Drager Syndrome Brain Diseases Apnea Sleep Apnea Syndromes Atrophy Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms 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

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