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Comparison of 2 hook-up protocols to perform home-based sleep studies in patients suspected of sleep-disordered breathing.
First one: hook-up is performed in the hospital, around 4 PM, and the patient go home with the portable monitoring.
Second one: hook-up is performed home, around 7 PM, and the patient has not to move after hook-up.
All the patients will undergo 2 polysomnographies, according to two different hook-up protocols, within 2 weeks. Order of the exams will be randomized.
We hypothesised that quality of recording is better when hook-up is performed at home.
Final polysomnographic diagnosis, with the 2 different techniques, must be similar.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| polysomnography for suspicion of SDB | Experimental | adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| polysomnography | Device | home-based polysomnography with hook-up performed ar at home or in the hospital |
|
| Measure | Description | Time Frame |
|---|---|---|
| Failure Rate of Sleep Study | failure rate of polysomnography according to the hook-up protocol. Polysomnographies scored as "poor" or "unsatisafctory" according to Redline et al. SLEEP 1998 are considered as failed. | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| marie Bruyneel, MD | CHU St Pierre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Saint Pierre | Brussels | 1000 | Belgium |
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| ID | Title | Description |
|---|---|---|
| FG000 | Home Hook-up First Then Hook-up in the Hospital | adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography polysomnography: home-based polysomnography with hook-up performed at home first. Croosover design. 2nd polysomnography with in-lab hook-up performed within 2 weeks |
| FG001 | Hospital Hook-up First, Then Home Hook-up | adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography polysomnography: home-based polysomnography with hook-up performed at the hospital Croosover design. 2nd polysomnography with home hook-up performed within 2 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 1 |
| |||||||||||||
| Wash-out, Maximum 2 Weeks |
| |||||||||||||
| Second Intervention |
|
patients suspected of OSA
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| ID | Title | Description |
|---|---|---|
| BG000 | Polysomnography for Suspicion of SDB | adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography polysomnography: home-based polysomnography with hook-up performed ar at home or in the hospital |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Failure Rate of Sleep Study | failure rate of polysomnography according to the hook-up protocol. Polysomnographies scored as "poor" or "unsatisafctory" according to Redline et al. SLEEP 1998 are considered as failed. | Posted | Number | percentage of participants | 1 day |
|
1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Home Hook up First | adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography polysomnography: home-based polysomnography with hook-up performed at home |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Marie Bruyneel | CHU St Pierre | 003225354219 | Marie_BRUYNEEL@stpierre-bru.be |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| ID | Term |
|---|---|
| D017286 | Polysomnography |
| ID | Term |
|---|---|
| D008991 | Monitoring, Physiologic |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| NOT COMPLETED |
|
| NOT COMPLETED |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 51 |
| 0 |
| 51 |
| EG001 | Lab Hook up First | adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography polysomnography: home-based polysomnography with hook-up performed in the sleep lab | 0 | 48 | 0 | 48 |
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| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |