Continuous Positive Airway Pressure (CPAP) for Primary Care

NCT02459548 | Completed

• 1 other identifier: 2010111082
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

OSA

Keywords

OSA; CPAP treatment; Primary care; Efficacy

Outcome Measures

Primary Outcomes (1)

• Number of hours of use per day of CPAP

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

  Six month

Secondary Outcomes (7)

• Level of clinical improvement evaluated through the Epworth Sleep Scale

  At baseline and at 6 month of follow-up

• Patient satisfaction (visual-analogical scale)

  Six month

• Adverse events (number of CPAP complications)

  Six month

• Quality of life (EuroQOL test)

  Baseline and at 6 month of follow up

• Comorbidity index (Charlson index)

  Six month

Other Outcomes (1)

• Anthropometric variables (Body mass index)

  Six month

Study Arms (2)

Primary Care Group

EXPERIMENTAL

This group will be follow up in Primary Care at 1, 3 and 6 month. At each visit patients receive advice on CPAP treatment, management of adverse effects associated with CPAP, making anthropometric and blood pressure measurements and also were asked to complete questionnaires.

Other: Follow up in Primary Care Group

Sleep Unit Group

OTHER

This group will be follow up in Sleep unit at 1, 3 and 6 month. At each visit patients receive advice on CPAP treatment, management of adverse effects associated with CPAP, making anthropometric and blood pressure measurements and also were asked to complete questionnaires.

Other: Follow up in Sleep Unit Group

Interventions

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.

Sleep Unit Group

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 Care Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women over 18 years old.
• Patients with OSA diagnosis performed in the sleep unit
• Written informed consent signed.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario Araba: lead
• Spain:Health Department. Basque Government.: collaborator
• Linde Health Care: collaborator

Study Sites (1)

Hospital Universitario Araba

Vitoria-Gasteiz, Araba, 01009, Spain

Location

Study Officials

• Joaquin Duran-Cantolla, MD

  Hospital Universitario Araba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Joaquin Duran-Cantolla, MD Hospital Universitario Araba, Vitoria-Gasteiz (Spain)

Study Record Dates

• First Submitted: April 1, 2015
• First Posted: June 2, 2015
• Study Start: February 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: May 1, 2016
• Last Updated: December 4, 2018

Record last verified: 2018-12

Locations

ES (1)