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

• ClinicalTrials.gov Identifier: NCT00743561
• Recruitment Status: Completed
• First Posted: August 29, 2008
• Last Update Posted: April 30, 2012
• Sponsor: University Hospital, Bordeaux
• 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

  Show Detailed Description

Study Design

• 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

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 :

1. 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 :

1. 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 ]
2. 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 ]
3. 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 ]
4. 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 ]
5. 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 ]
6. 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 ]
7. 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

• 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

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

• Responsible Party: University Hospital, Bordeaux
• ClinicalTrials.gov Identifier: NCT00743561 History of Changes
• Other Study ID Numbers: CHUBX - 2007/04
• First Posted: August 29, 2008
• 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:

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