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Completed

NCT Number: NCT02779894

Sleep Apnoea Management by a Communication Based Technology (ICT)

This project develops a new form of management of subjects with suspected SAHS and different sleep disorders by applying Information and communications technologies (ICT).

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clinic

Barcelona, 08036, Spain

About this study

Sleep apnea hypopnea syndrome (SAHS) is a prevalent disease with significant morbidity resulting in long waiting lists and high health care costs. Therefore, alternative cost-effective approaches are urgently needed. A possible procedure is telemedicine based on ICT.

The design of the study is prospective, randomized, controlled, open and parallel.

A ICT-based out of hospital management of SAHS is implemented to be compared with the classical in-hospital management.

The main objectives were the evaluation of both groups and the analysis of efficacy and cost effectiveness of two SAHS management programs.

This is a 3 month randomized, with parallel groups study. Participants will be patients with suspicion of SAHS derived to the Investigators' Sleep Unit.

Patients are randomized in two groups; 1) classical in-hospital group: polysomnography or home respiratory polygraphy (HRP), CPAP titration and treatment and hospital follow-up; and 2) ICT group: 3 consecutive HRPs, automatic CPAP treatment and control by phone/video conferences and data transmission by using a custom designed platform.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical suspicion of SAHS
  • Use of Smartphone and internet

Exclusion criteria

  • Severe hypersomnia
  • Central apneas or other sleep disorder
  • Previous CPAP treatment
  • Unstable diseases
  • Profession of risk
  • Not able to complete questionnaires
  • No written informed consent

Treatment and study plan

Remote control of patients

Other

Diagnosis outside the hospital (3 Home PR) CPAP (if needed) titration at home REmote control of patient's during 3 months by video or phonoconference

Other names: Communication based technology

Primary outcomes

  1. Evaluation of the two SAHS management programs

    Time frame: 3 months

    Quebec sleep questionnaire

  2. Evaluation of the two SAHS management programs

    Time frame: 3 months

    Compliance to CPAP treatment. (Number of hours that the patient uses CPAP)

Secondary outcomes

  1. Cost-effectiveness of the two SAHS management programs

    Time frame: 3 months

    Costs of visits and transport of both groups (Bayesian analysis techniques)

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Official study title

Applicability, Efficacy and Cost Effectiveness of Sleep Apnoea Hypopnea Syndrome (SAHS) Management by an Information and Communication Based Technology (ICT)

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 23, 2016
Registry last updated
Feb 26, 2018

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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