Assessment of Ambulatory Polygraphy in the Detection of Sleep Apnea in Multiple System Atrophy (SAMSA)
Condition: Sleep Apnea Syndromes; Multiple System Atrophy
MeSH terms: Apnea; Sleep Apnea Syndromes; Multiple System Atrophy; Shy-Drager Syndrome; Atrophy
Study type: Interventional

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).
    

Intervention name(s): Polysomnography; ambulatory polygraphy
Intervention type(s): Device; Device
Intervention description(s): 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; Simultaneous recording of nasal air flow, oxygen saturation, as well as the abdominal and thoracic respiratory effort.
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: MSA; sleep apnea; ambulatory polygraphy; polysomnography