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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

Tracking Information
First Submitted Date  ICMJE August 28, 2008
First Posted Date  ICMJE August 29, 2008
Last Update Posted Date April 30, 2012
Study Start Date  ICMJE June 2008
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00743561 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of Ambulatory Polygraphy in the Detection of Sleep Apnea in Multiple System Atrophy (SAMSA)
Official Title  ICMJE Study of the Performance of Ambulatory Nocturnal Polygraphy in the Diagnosis of Sleep Apnea in Multiple System Atrophy
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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Sleep Apnea Syndromes
  • Multiple System Atrophy
Intervention  ICMJE
  • 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.
Study Arms  ICMJE 1
Interventions:
  • Device: Polysomnography
  • Device: ambulatory polygraphy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 28, 2008)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00743561
Other Study ID Numbers  ICMJE CHUBX - 2007/04
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Bordeaux
Study Sponsor  ICMJE University Hospital, Bordeaux
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Wassilios Meissner, MD PhD University Hospital Bordeaux, France
Study Chair: Paul PEREZ, MD, PhD USMR, University Hospital, Bordeaux
PRS Account University Hospital, Bordeaux
Verification Date April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP