Continuous Positive Airway Pressure (CPAP) for Primary Care

OSA Clinical Trial

— CPAP-SU-MAP  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02459548
• Other study ID #: 2010111082
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: May 2016

Study information

• Verified date: December 2018
• Source: Hospital Universitario Araba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: May 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• OSA

Intervention

Other:
• Follow up in Sleep Unit Group
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
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.

Locations

Country	Name	City	State
Spain	Hospital Universitario Araba	Vitoria	Araba

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Universitario Araba	Linde Health Care, Spain:Health Department. Basque Government.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anthropometric variables (Body mass index)	Body mass index	Six month
Primary	Number of hours of use per day of CPAP	Compare the objective CPAP compliance treatment in the two study groups.	Six month
Secondary	Level of clinical improvement evaluated through the Epworth Sleep Scale	Evaluate the level of clinical improvement from the start of treatment until 6 months by the changes in the Epworth Sleep Scale	At baseline and at 6 month of follow-up
Secondary	Patient satisfaction (visual-analogical scale)	Evaluate the level of patient's satisfaction by visual-analogical scale.	Six month
Secondary	Adverse events (number of CPAP complications)	Determine the number of CPAP complications (secondary effects).	Six month
Secondary	Quality of life (EuroQOL test)	Evaluate by EuroQOL test	Baseline and at 6 month of follow up
Secondary	Comorbidity index (Charlson index)	Charlson index	Six month
Secondary	Blood pressure	Blood pressure measurements	Six month
Secondary	Cost-effectiveness analysis	Cost-efficacy evaluation	Six month