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The purpose of this study is to develop an efficient home-based polysomnography device, which allows, through GPRS,continuous real-time monitoring from the sleep lab based in the hospital, in order to decrease the failure rate of home-based recordings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| telematic attended polysomnography | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| polysomnograph Dream and Sleep Box | Device | Portable polysomnograph will be placed at home around 7:00PM. The Sleep Box (wireless monitoring device) will be left near the patient, to allow real-time GPRS transmission of recorded sleep parameters to the sleep lab. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Polysomnographic Recordings | Quality of recordings will be graded according to Redline S et al (SLEEP 1998): Unsatisfactory, poor, fair, good, very good,excellent. Unsatisfactory and poor recordings are considered as failures. | 1 week |
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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 St Pierre | Brussels | 1000 | Belgium |
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Recruitment took place in the Sleep Lab of a tertiary hospital. Patients were recruted for ploysomnography if they were clinically suspicted of OSA.
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| ID | Title | Description |
|---|---|---|
| FG000 | Telematic Attended Polysomnography | All patients underwent one Home-PSG, using Dream and Sleepbox (Medatec, Belgium), that is a wireless system able to communicate with Dream, and with Internet through a wi-fi/3G interface. It is equipped with a digital infrared camera, and with a speaker/microphone system for bidirectional audio/video communication via Skype. The Sleep Lab nurse performed a discontinue monitoring of the PSG. In case of defective signals, she called the patient who had been previously educated to replace the sensors. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Telematic Attended Polysomnography | All patients underwent one Home-PSG, using Dream and Sleepbox (Medatec, Belgium), that is a wireless system able to communicate with Dream, and with Internet through a wi-fi/3G interface. It is equipped with a digital infrared camera, and with a speaker/microphone system for bidirectional audio/video communication via Skype. The Sleep Lab nurse performed a discontinue monitoring of the PSG. In case of defective signals, she called the patient who had been previously educated to replace the sensors. |
| 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 | Quality of Polysomnographic Recordings | Quality of recordings will be graded according to Redline S et al (SLEEP 1998): Unsatisfactory, poor, fair, good, very good,excellent. Unsatisfactory and poor recordings are considered as failures. | Posted | Number | percentage of recording failure | 1 week |
|
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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 | Telematic Attended Polysomnography | All patients underwent one Home-PSG, using Dream and Sleepbox (Medatec, Belgium), that is a wireless system able to communicate with Dream, and with Internet through a wi-fi/3G interface. It is equipped with a digital infrared camera, and with a speaker/microphone system for bidirectional audio/video communication via Skype. The Sleep Lab nurse performed a discontinue monitoring of the PSG. In case of defective signals, she called the patient who had been previously educated to replace the sensors. |
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-technical problems with the Skype® connection
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Marie Bruyneel | CHU St Pierre | 003225354219 | marie_bruyneel@tpierre-bru.be |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| 0 |
| 21 |
| 0 |
| 21 |
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| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |