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Telemedicine for Sleep Apnea Patients (Respir@dom)

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ClinicalTrials.gov Identifier: NCT01848509
Recruitment Status : Completed
First Posted : May 7, 2013
Last Update Posted : December 4, 2014
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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

Condition or disease Intervention/treatment Phase
Sleep Apnea Device: With teletransmission Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 201 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Telemedicine System for the Follow-up of Patients With SAS
Study Start Date : April 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
No Intervention: Without telemonitoring
Without teletransmission of alerts
Experimental: With telemonitoring
With teletransmission of alerts
Device: With teletransmission
Teletransmission of alerts




Primary Outcome Measures :
  1. CPAP adherence measured by the number of hours of nightly use [ Time Frame: 3 Months ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01848509


Locations
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France
Assistance Publique - Hôpitaux de Paris, Béclère Hospital
Clamart, France, 92141
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Pierre ESCOURROU, MD, PhD AP-HP - Antoine Béclère Hospital

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01848509     History of Changes
Other Study ID Numbers: 2012-A00713-40
K120501 ( Other Identifier: APHP - Clinical research department )
First Posted: May 7, 2013    Key Record Dates
Last Update Posted: December 4, 2014
Last Verified: December 2014

Keywords provided by Assistance Publique - Hôpitaux de Paris:
CPAP
adherence
SAOS
telemedicine

Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases