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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 220
- Locations
- 2
- Primary Endpoint
- Number of hours of use per day of CPAP
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Primary Care Group
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.
Intervention: Follow up in Primary Care Group (Other)
Sleep Unit Group
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.
Intervention: Follow up in Sleep Unit Group (Other)
Outcomes
Primary Outcomes
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
- Patient satisfaction (visual-analogical scale)(Six month)
- Adverse events (number of CPAP complications)(Six month)
- Comorbidity index (Charlson index)(Six month)
- Level of clinical improvement evaluated through the Epworth Sleep Scale(At baseline and at 6 month of follow-up)
- Quality of life (EuroQOL test)(Baseline and at 6 month of follow up)
- Blood pressure(Six month)
- Cost-effectiveness analysis(Six month)
Investigators
Joaquin Duran-Cantolla, MD
Joaquin Duran-Cantolla, MD Hospital Universitario Araba, Vitoria-Gasteiz (Spain)
Hospital Universitario Araba