Assessment of Ambulatory Polygraphy in the Detection of Sleep Apnea in Multiple System Atrophy (SAMSA)

NCT00743561 | Completed

• 1 other identifier: CHUBX - 2007/04
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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).

Conditions

Sleep Apnea Syndromes; Multiple System Atrophy

Keywords

MSA; sleep apnea; ambulatory polygraphy; polysomnography

Outcome Measures

Primary Outcomes (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.

  1 month

Secondary Outcomes (7)

• 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.

  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).

  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).

  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).

  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).

  1 month

Study Arms (1)

1

OTHER

Device: Polysomnography; Device: ambulatory polygraphy

Interventions

Polysomnography DEVICE

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

1

ambulatory polygraphy DEVICE

Simultaneous recording of nasal air flow, oxygen saturation, as well as the abdominal and thoracic respiratory effort.

1

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Progressive cancer
• Significant cognitive impairment (MMSE\<24)
• Sleep apnea
• Respiratory disorder
• Less than one year since previous polysomnography or ambulatory polygraphy

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (2)

CHU de Bordeaux - Hôpital Pellegrin

Bordeaux, 33096, France

Location

CHU de Bordeaux - Hôpital du Haut-Lévêque - Département de Neurologie - Centre de référence nationale maladie rare AMS

Pessac, 33604, France

Location

Related Publications (2)

• Meissner WG, Flabeau O, Perez P, Taillard J, Marquant F, Dupouy S, Tison F, Philip P, Ghorayeb I. Accuracy of portable polygraphy for the diagnosis of sleep apnea in multiple system atrophy. Sleep Med. 2014 Apr;15(4):476-9. doi: 10.1016/j.sleep.2013.12.013. Epub 2014 Feb 21.

  PMID: 24656908 RESULT

• Flabeau O, Ghorayeb I, Perez P, Maillard A, Taillard J, Philip P, Foubert-Samier A, Tison F, Meissner WG. Impact of sleep apnea syndrome on survival in patients with multiple system atrophy. Parkinsonism Relat Disord. 2017 Feb;35:92-95. doi: 10.1016/j.parkreldis.2016.12.013. Epub 2016 Dec 16.

  PMID: 28011164 RESULT

MeSH Terms

Conditions

Sleep Apnea Syndromes; Multiple System Atrophy

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Wassilios Meissner, MD PhD

  University Hospital Bordeaux, France

  PRINCIPAL INVESTIGATOR

• Paul PEREZ, MD, PhD

  USMR, University Hospital, Bordeaux

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2008
• First Posted: August 29, 2008
• Study Start: June 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: January 1, 2011
• Last Updated: May 14, 2026

Record last verified: 2012-04

Locations

FR (2)