Assessment of Ambulatory Polygraphy in the Detection of Sleep Apnea in Multiple System Atrophy (SAMSA)
NCT ID: NCT00743561
Last Updated: 2012-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2008-06-30
2011-01-31
Brief Summary
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Detailed Description
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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).
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
SINGLE
Study Groups
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1
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
ambulatory polygraphy
Simultaneous recording of nasal air flow, oxygen saturation, as well as the abdominal and thoracic respiratory effort.
Interventions
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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
ambulatory polygraphy
Simultaneous recording of nasal air flow, oxygen saturation, as well as the abdominal and thoracic respiratory effort.
Eligibility Criteria
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Inclusion Criteria
* Age 30-80 years
* Oral informed consent of patient or representative
* Patient requiring hospitalization in a neurology unit
Exclusion Criteria
* Significant cognitive impairment (MMSE\<24)
* Sleep apnea
* Respiratory disorder
* Less than one year since previous polysomnography or ambulatory polygraphy
30 Years
80 Years
ALL
No
Sponsors
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University Hospital, Bordeaux
OTHER
Responsible Party
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Principal Investigators
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Wassilios Meissner, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Bordeaux, France
Paul PEREZ, MD, PhD
Role: STUDY_CHAIR
USMR, University Hospital, Bordeaux
Locations
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CHU de Bordeaux - Hôpital Pellegrin
Bordeaux, , France
CHU de Bordeaux - Hôpital du Haut-Lévêque - Département de Neurologie - Centre de référence nationale maladie rare AMS
Pessac, , France
Countries
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Other Identifiers
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CHUBX - 2007/04
Identifier Type: -
Identifier Source: org_study_id