Assessment of Ambulatory Polygraphy in the Detection of Sleep Apnea in Multiple System Atrophy (SAMSA)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

University Hospital, Bordeaux

ClinicalTrials.gov Identifier:

NCT00743561

First received: August 28, 2008

Last updated: April 27, 2012

Last verified: April 2012

History of Changes

Purpose

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	Intervention
Sleep Apnea Syndromes Multiple System Atrophy	Device: Polysomnography Device: ambulatory polygraphy

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Single Blind (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

Resource links provided by NLM:

Genetics Home Reference related topics: multiple system atrophy

MedlinePlus related topics: Sleep Apnea

U.S. FDA Resources

Further study details as provided by University Hospital, Bordeaux:

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Enrollment:	30
Study Start Date:	June 2008
Study Completion Date:	January 2011
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Show Detailed Description

Eligibility

Ages Eligible for Study:	30 Years to 80 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00743561

Locations

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

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

More Information

No publications provided

Responsible Party:	University Hospital, Bordeaux
ClinicalTrials.gov Identifier:	NCT00743561 History of Changes
Other Study ID Numbers:	CHUBX - 2007/04
Study First Received:	August 28, 2008
Last Updated:	April 27, 2012
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:

MSA
sleep apnea
ambulatory polygraphy
polysomnography

Additional relevant MeSH terms:

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

Primary Dysautonomias
Basal Ganglia Diseases
Brain Diseases
Movement Disorders
Neurodegenerative Diseases
Hypotension
Vascular Diseases
Cardiovascular Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 16, 2013

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