Skip to main content
OpenTrials
Completed

NCT Number: NCT02459548

Continuous Positive Airway Pressure (CPAP) for Primary Care

The objective of the study is to compare the results of a follow-up and treatment coordinate and interactive program performed by the General Practitioners (GP) for Obstructive Sleep Apnea (OSA) patients treated with positive continuous pressure (CPAP) vs. usual control by sleep specialists from the sleep unit.

METHODOLOGY: DESIGN: Randomized comparative study. It will include patients with diagnosis of severe OSA that should start treatment with CPAP. Participating center is Hospital Universitario Araba in Vitoria-Gasteiz (Spain). These patients will be randomized to two monitoring groups : 1 monitoring in the sleep unit; 2: monitoring in primary care consultations by the General Practitioners (GP), once the OSA diagnosis has been made and it was indicated the treatment with CPAP.

Patients will be carried out in both groups the same follow-up visits in two study arms: basal, 1 month, 3 month and 6 months. PRIMARY OUTCOME: To compare the objective CPAP compliance treatment in the two study groups, so that use >= 4h/day is defined as good adherence to the treatment. SECONDARY OUTCOMES: 1)To evaluate the level of patient's satisfaction by visual-analogical scales and quality of life tests; 2) to establish the clinical improvement by somnolence and sleep scales; 3) To determine the numbers of CPAP complications, type, severity and duration; 4) To figure-out the level of take care of the CPAP machine, substitutions and complements, assistance and technical incidents; 5) Cost-effectiveness analysis.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

OSA

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Araba

Vitoria-Gasteiz, Araba, 01009, Spain

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.
  • Patients with OSA diagnosis performed in the sleep unit
  • Written informed consent signed.

Exclusion criteria

  • Previous CPAP treatment for OSA diagnosis
  • Psycho-physical inability to complete questionnaires
  • Presence of any previously diagnosed sleep disorders: narcolepsy, insomnia, chronic sleep deprivations, regular use of hypnotic or sedative medications nad restless leg syndrome
  • Patients with respiratory diseases (overlap syndrome, hypoventilation, restrictive diseases)
  • A medical history that may interfere with the study objectives or, in the opinion of the investigator, compromise the conclusions.

Treatment and study plan

Follow up in Sleep Unit Group

Other

Compare the results of a program of treatment and follow-up by Primary Care in patients with obstructive sleep apnea on CPAP treatment, versus the usual practice of control by the Sleep Unit.

Follow up in Primary Care Group

Other

Compare the results of a program of treatment and follow-up by Primary Care in patients with obstructive sleep apnea on CPAP treatment, versus the usual practice of control by the Sleep Unit.

Primary outcomes

  1. Number of hours of use per day of CPAP

    Time frame: Six month

    Compare the objective CPAP compliance treatment in the two study groups.

Secondary outcomes

  1. Level of clinical improvement evaluated through the Epworth Sleep Scale

    Time frame: At baseline and at 6 month of follow-up

    Evaluate the level of clinical improvement from the start of treatment until 6 months by the changes in the Epworth Sleep Scale

  2. Patient satisfaction (visual-analogical scale)

    Time frame: Six month

    Evaluate the level of patient's satisfaction by visual-analogical scale.

  3. Adverse events (number of CPAP complications)

    Time frame: Six month

    Determine the number of CPAP complications (secondary effects).

  4. Quality of life (EuroQOL test)

    Time frame: Baseline and at 6 month of follow up

    Evaluate by EuroQOL test

  5. Comorbidity index (Charlson index)

    Time frame: Six month

    Charlson index

  6. Blood pressure

    Time frame: Six month

    Blood pressure measurements

  7. Cost-effectiveness analysis

    Time frame: Six month

    Cost-efficacy evaluation

Other outcomes

  1. Anthropometric variables (Body mass index)

    Time frame: Six month

    Body mass index

Sponsors and collaborators

Lead sponsor

Hospital Universitario Araba

Other

Collaborators

  • Basque Government Department of Public Health
  • Linde Health Care

Registry information

Official study title

Validation of a Programme of Treatment and Follow-Up for Obstructive Sleep Apnea (OSA) Patients to be Applied by General Practitioners (GPs). Collaborative Network System Between GPs, CPAP Provider Enterprise and Sleep Specialists

Acronym: CPAP-SU-MAP

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Jun 2, 2015
Registry last updated
Dec 4, 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.

Published trials that share one or more normalized conditions with this study.