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OpenTrials
Completed

NCT Number: NCT02517346

Efficacy of Telemonitoring on CPAP Treatment Compliance in Obstructive Sleep Apnea (OSA) Patients

The purpose of this study is to compare the effectiveness of telemonitoring versus standard follow-up on CPAP treatment compliance in Obstructive Sleep Apnea Syndrome (OSAS).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Arnau de Vilanova-Santa María

Lleida, 25198, Spain

About this study

Obstructive Sleep Apnea (OSA) is defined by the presence of repetitive episodes of upper airways collapse during sleep, leading to nocturnal hypoxemia, sleep fragmentation and daytime sleepiness. When untreated, OSA is a risk factor for arterial hypertension , cardiovascular and cerebrovascular diseases, road accidents and a worse quality of life. The application of a continuous positive airways pressure (CPAP) represents the first line therapy in patients with moderate to severe OSA. CPAP treatment improves daytime sleepiness and oxygen saturation , reduces cardiovascular risk, ameliorates neurobehavioral performance, improves quality of life and reduces road accidents. Despite its demonstrated efficacy, CPAP effectiveness is significantly limited by poor adherence. A closer follow up could improve CPAP adherence but it would take up more work and additional costs for sleep units.

So on that account, the investigators propose a study to demonstrate that automatic home treatment monitoring of patients with OSA is a cost-effectiveness alternative approach to patient's management. Moreover, the investigators believe that telemonitoring could improve CPAP compliance and patient's satisfaction and reduce follow-up costs.

Methods:

Prospective and randomized study during three months. Patients diagnosed as OSA in St. Maria's Hospital (Sleep Unit) and requiring CPAP treatment, will be randomized into two groups differing in CPAP compliance monitoring and management .

Group 1 Standard care Patients will be fitted with a mask and given a CPAP and instructed on how to use the device. Patients will follow the standard treatment management. All patients will be visited at 1 month at sleep unit. Patients will be checked about progress and adherence to therapy and any problems with their machine. Information will be downloaded from their machines (CPAP adherence, applied CPAP pressure, mask leak, and residual respiratory events…).

Group 2 Telemonitoring Patients will be fitted with a mask and given a CPAP. Each CPAP device will be provided with a modem sending daily compliance information (CPAP adherence, CPAP pressure, mask leak, and residual respiratory events) to a web database.

Patients of both 2 groups will be finally visited at 3 months at sleep unit.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Men and Women over 18 years old
  • Diagnosed as OSA and requiring CPAP treatment
  • Written informed consent form signed.

Exclusion criteria

  • Patients with impaired lung function (overlap syndrome, obesity hypoventilation syndrome, and restrictive disorders)
  • Severe heart failure
  • Severe chronic pathology associated
  • Psychiatric disorder
  • Periodic leg movements
  • Pregnancy
  • Other dyssomnias or parasomnias
  • Patients already treated with CPAP

Treatment and study plan

standard follow-up

Other

Standard management according to Spanish Respiratory Society guidelines in Sleep Unit.

Telemonitoring

Other

Follow up by telemonitoring system during 3 months

Primary outcomes

  1. CPAP adherence at 3 months

    Time frame: 3 months

    Number of hours of use per day of CPAP according to the internal clock of the CPAP device

Secondary outcomes

  1. Patients' satisfaction at 3 months

    Time frame: 3 months

    Patients will be asked to grade their satisfaction with the follow up care provided by telemonitoring /sleep unit using a questionnaire and a visual analogue scale.

  2. Cost effectiveness at 3 months

    Time frame: 3 months

    Costs in each group (CPAP carrying charge, number of visits and calls, number of hospital admissions) will be compared.

  3. Change from baseline in quality of life at 3 months

    Time frame: 3 months

    EuroQOL health questionnaire and visual analogue scale will be used.

  4. Fast detection of the non-adherent patient with telemonitoring

    Time frame: 3 months

    We assume that telemonitoring could quickly detect non- adherent patients.

  5. Change in blood pressure at 3 months

    Time frame: 3 months

  6. Change in body mass index at 3 months

    Time frame: 3 months

  7. Abandons at 3 months

    Time frame: 3 months

    Number of patients lost at follow up at 3 months of CPAP therapy.

  8. Adverse events at 3 months

    Time frame: 3 months

  9. Change from baseline in snoring at 3 months

    Time frame: 3 months

    Patients will be asked about the persistence of snoring

  10. Change from baseline in witnessed apneas at 3 months

    Time frame: 3 months

    Patients will be asked about the persistence of witnessed apneas

  11. Change from baseline in nocturia at 3 months

    Time frame: 3 months

    Patients will be asked about the presence of nocturia.

  12. Change from baseline in daytime sleepiness at 3 months

    Time frame: 3 months

    Epworth sleepiness scale will be used.

  13. Changes in nocturnal gasping at 3 months

    Time frame: 3 months

    Patients will be asked about the persistence of nocturnal gasping

  14. Changes in sleep fragmentation at 3 months

    Time frame: 3 months

    Patients will be asked about the persistence of sleep fragmentation/maintenance insomnia

  15. Presence of symptoms of restlees leg syndrome at 3 months

    Time frame: 3 months

    Patients will be asked about the presence of symptoms of restless leg syndrome

Sponsors and collaborators

Lead sponsor

Sociedad Española de Neumología y Cirugía Torácica

Other

Collaborators

  • Asociacio Lleidatana de Respiratori
  • ResMed

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Aug 7, 2015
Registry last updated
Apr 15, 2016

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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