NCT01848509

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
201

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2013

Completed
27 days until next milestone

First Posted

Study publicly available on registry

May 7, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

December 4, 2014

Status Verified

December 1, 2014

Enrollment Period

1.2 years

First QC Date

April 10, 2013

Last Update Submit

December 3, 2014

Conditions

Sleep Apnea

Keywords

CPAPadherenceSAOStelemedicine

Outcome Measures

Primary Outcomes (1)

  • CPAP adherence measured by the number of hours of nightly use

    3 Months

Secondary Outcomes (5)

  • economics: cost estimation: investment and running costs

    3 months

  • Quality of life

    3 months

  • 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

Study Arms (2)

Without telemonitoring

NO INTERVENTION

Without teletransmission of alerts

With telemonitoring

EXPERIMENTAL

With teletransmission of alerts

Device: With teletransmission

Interventions

With teletransmissionDEVICE

Teletransmission of alerts

With telemonitoring

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • AHI \> 30/hr
  • hypersomnolence
  • agreement for the use of CPAP
  • internet and GSM connection

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique - Hôpitaux de Paris, Béclère Hospital

Clamart, 92141, France

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Pierre ESCOURROU, MD, PhD

    AP-HP - Antoine Béclère Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2013

First Posted

May 7, 2013

Study Start

April 1, 2013

Primary Completion

June 1, 2014

Study Completion

September 1, 2014

Last Updated

December 4, 2014

Record last verified: 2014-12

Locations

FR(1)