Sleep Apnea
Conditions
Keywords
CPAP, adherence, SAOS, telemedicine
Brief summary
Objective: Set up an interoperable telemedicine system for the follow-up of patients with sleep apnea syndrome.
Detailed description
The medico-economics protocol will use the MAST (Methodology for Assessment of Telemedicine) criteria. 200 patients will be randomized into 2 arms (telemedicine with GPRS transmission of CPAP data from patients' home and classical follow-up) during the 3 first months of the follow-up. The main end-point is CPAP compliance with the aim of detecting a mean increase of at least 1hr in the use of CPAP.
Interventions
DEVICEWith teletransmission
Teletransmission of alerts
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* AHI \> 30/hr * hypersomnolence * agreement for the use of CPAP * internet and GSM connection
Exclusion criteria
* central apnea \>20%, * pneumothorax, * severe nasal obstruction, * previous pharyngeal surgery, * severe COPD, * heart failure, * previous use of CPAP, * no social security coverage, * unavailability, * no GSM and internet network
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CPAP adherence measured by the number of hours of nightly use | 3 Months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| economics: cost estimation: investment and running costs | 3 months | — |
| Quality of life | 3 months | SF36 (french version) and FOSQ (Functional Outcomes of Sleep Questionnaire) |
| Organizational changes of home care providers and medical structures | 9 months after the first patient inclusion | — |
| Perception of healthcare professionals (autoquestionnaire RENEWING HEALTH) | 3 months | — |
| Patients satisfaction | 3 months | — |
Countries
France
Outcome results
None listed