Obstructive Sleep Apnea
Conditions
Keywords
sleep apnea, polysomnography, telemedicine
Brief summary
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.
Interventions
DEVICEpolysomnograph Dream and Sleep Box
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.
Sponsors
Centre Hospitalier Universitaire Saint Pierre
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* clinical suspicion of OSA * 18 y old
Exclusion criteria
* restrictive respiratory disorders * distance home-hospital exceeding 30 Km.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Polysomnographic Recordings | 1 week | 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. |
Countries
Belgium
Participant flow
Recruitment details
Recruitment took place in the Sleep Lab of a tertiary hospital. Patients were recruted for ploysomnography if they were clinically suspicted of OSA.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 21 |
| Total | 21 |
Baseline characteristics
| Characteristic | Telematic Attended Polysomnography |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants |
| Age Continuous | 50 years STANDARD_DEVIATION 11 |
| Region of Enrollment Belgium | 21 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 |
Outcome results
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.
Time frame: 1 week
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telematic Attended Polysomnography | Quality of Polysomnographic Recordings | 10 percentage of recording failure |