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Completed

NCT Number: NCT01848509

Telemedicine for Sleep Apnea Patients

Objective: Set up an interoperable telemedicine system for the follow-up of patients with sleep apnea syndrome.

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Key information

Conditions

Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique - Hôpitaux de Paris, Béclère Hospital

Clamart, 92141, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

With teletransmission

Device

Teletransmission of alerts

Primary outcomes

  1. CPAP adherence measured by the number of hours of nightly use

    Time frame: 3 Months

Secondary outcomes

  1. economics: cost estimation: investment and running costs

    Time frame: 3 months

  2. Quality of life

    Time frame: 3 months

    SF36 (french version) and FOSQ (Functional Outcomes of Sleep Questionnaire)

  3. Organizational changes of home care providers and medical structures

    Time frame: 9 months after the first patient inclusion

  4. Perception of healthcare professionals (autoquestionnaire RENEWING HEALTH)

    Time frame: 3 months

  5. Patients satisfaction

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

A Telemedicine System for the Follow-up of Patients With SAS

Acronym: Respir@dom

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 7, 2013
Registry last updated
Dec 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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