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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Shy-Drager Syndrome
Apnea
Multiple System Atrophy
Sleep Apnea Syndromes
Atrophy
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Basal Ganglia Diseases
Brain Diseases
Central Nervous System 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 July 20, 2014