Follow-up of Patients With the Apnea-hypopnea Syndrome in Primary Care and Sleep Disorders Units. Equivalence Randomized Comparative Study on Compliance and Clinical Response.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 210
- Locations
- 1
- 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 coordinated and interactive program for the treatment, monitoring and control of patients with a moderate-severe diagnosis of Obstructive Sleep Apnea (OSA) and treated with positive continuous pressure (CPAP), with the currently established situation.
Methodology: Equivalence randomized comparative study . It will include patients with diagnosis of moderate-severe OSA (apnea-hypopnea Index >=15) that should start treatment with (CPAP). Participating center is Hospital Santa María-Arnau de Vilanova in Lleida (Spain).These patients will be randomized to two monitoring groups (1: monitoring in the Sleep disorders unit, 2: monitoring in primary care consultations) once the OSAS diagnosis has been made and it was indicated that treatment with CPAP. Patients Will be carried out in both groups the same follow-up visits in two study arms: basal, 1 month, 3 months and 6 months. Primary outcomes: number of hours of use per day (according to the accountant of the CPAP), so that use >= 4h/day is defined as good adherence to the treatment. Secondary outcomes: daytime sleepiness, patient satisfaction, Adverse events related to CPAP treatment. It will be collected demographic ,clinics and anthropometric variables. At the end of follow-up primary and secondary outcomes will be compared between two groups.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- 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 units
- •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 deprivation, regular use of hypnotic or sedative medications and 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.
- •Any medical factor, social or geographical, that may jeopardize patient compliance.(e.g., alcohol consumption (more 80 gr/day in men and more than 60 gr / day in women), no fixed address, disorientation, or a history of non-compliance).
Arms & Interventions
Sleep Unit group
This group will have standard follow up in sleep unit at 1, 3 and 6 month. These patients will also be instructed in hygienic-dietary measures, standard care of cardiovascular risk factors and sleep hygiene counseling.
Primary Care group
This group will have standard follow up in primary care at 1, 3 and 6 month. These patients will also be instructed in hygienic-dietary measures, standard care of cardiovascular risk factors and sleep hygiene counseling.
Intervention: Clinical follow up by general practitioners in primary care (Other)
Outcomes
Primary Outcomes
Number of hours of use per day of CPAP
Time Frame: Six month
Number of hours of use per day of CPAP according to the internal clock of the CPAP device
Secondary Outcomes
- Adverse events(Six month)
- Blood pressure(Sixt month)
- Lost of follow up(Six month)
- Daytime sleepiness(At baseline and at 6 month of follow-up)
- Comorbidity index(Six month)
- Patient satisfaction(Six month)
- Quality of life(Baseline and at 6 month of follow up)
- Cost-efficacy evaluation(Six month)
Investigators
Ferran Barbe
MD
Sociedad Española de Neumología y Cirugía Torácica