Sleep Apnea SyndromesNCT00743561
Assessment of Ambulatory Polygraphy in the Detection of Sleep Apnea in Multiple System Atrophy (SAMSA)
A study testing Polysomnography and ambulatory polygraphy in people with Sleep Apnea Syndromes and Multiple System Atrophy, run by University Hospital, Bordeaux at 2 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Sleep Apnea Syndromes, Multiple System Atrophy
- What is being tested?
- Polysomnography and ambulatory polygraphy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesFrance
- Study dates
- Jun 2008to Jan 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Progressive cancer
- Significant cognitive impairment (MMSE<24)
- Sleep apnea
- Respiratory disorder
- Less than one year since previous polysomnography or ambulatory polygraphy
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU de Bordeaux - Hôpital Pellegrin
Bordeaux, 33096
CHU de Bordeaux - Hôpital du Haut-Lévêque - Département de Neurologie - Centre de référence nationale maladie rare AMS
Pessac, 33604
About this study
Official title: Study of the Performance of Ambulatory Nocturnal Polygraphy in the Diagnosis of Sleep Apnea in Multiple System Atrophy
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).
Read the 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).
- Conditions
- Sleep Apnea Syndromes, Multiple System Atrophy
- Being tested
- Polysomnography, ambulatory polygraphy
- Keywords
- MSA, sleep apnea, ambulatory polygraphy, polysomnography
- Medical subject headings
- Sleep Apnea Syndromes, Multiple System Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolysomnographyDevice
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 polygraphyDevice
Simultaneous recording of nasal air flow, oxygen saturation, as well as the abdominal and thoracic respiratory effort.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Not described Receives: Device: Polysomnography; Device: ambulatory polygraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2008 (estimated)
- Study startJun 2008
- Primary completionDec 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea SyndromesStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wassilios Meissner, MD PhD, Principal investigator, University Hospital Bordeaux, FrancePaul PEREZ, MD, PhD, Study chair, USMR, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00743561
- Sponsor's protocol ID
- CHUBX - 2007/04
- Status last verified
- Apr 2012
- First submitted
- 28 Aug 2008
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24656908Flabeau 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.
PubMed 28011164
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Performance of Ambulatory Nocturnal Polygraphy in the Diagnosis of Sleep Apnea in Multiple System Atrophy
- ClinicalTrials.gov ID
- NCT00743561
- Acronym / sponsor ID
- CHUBX - 2007/04
- Conditions
- Sleep Apnea Syndromes, Multiple System Atrophy
- Keywords
- MSA, sleep apnea, ambulatory polygraphy, polysomnography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 29 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Device: Polysomnography, Device: ambulatory polygraphy |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Progressive cancer
- Significant cognitive impairment (MMSE<24)
- Sleep apnea
- Respiratory disorder
- Less than one year since previous polysomnography or ambulatory polygraphy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PolysomnographySimultaneous 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 | 1 |
| ambulatory polygraphySimultaneous recording of nasal air flow, oxygen saturation, as well as the abdominal and thoracic respiratory effort. | Device | 1 |
Primary outcome
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
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Results publication: PubMed 24656908Meissner 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.
- Results publication: PubMed 28011164Flabeau 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wassilios Meissner, MD PhD principal investigator
University Hospital Bordeaux, France
Paul PEREZ, MD, PhD study chair
USMR, University Hospital, Bordeaux
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polysomnography and ambulatory polygraphy in people with Sleep Apnea Syndromes and Multiple System Atrophy, run by University Hospital, Bordeaux at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00743561, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.