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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
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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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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

MedlinePlus related topics: Sleep Apnea

Arms and Interventions
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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
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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
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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
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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     History of Changes
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