Clinical trial NCT01918449: Follow-up of Patients With Obstructive Sleep Apnea in Primary Care.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: OSA
Keywords: OSA
CPAP treatment
primary care
efficacy
Lead sponsor: Sociedad Española de Neumología y Cirugía Torácica
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
name: Fundacio Catalana de Pneumologia
First posted: 2013-08-07
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Number of hours of use per day of CPAP
timeFrame: Six month
Secondary outcomes:
measure: Daytime sleepiness
timeFrame: At baseline and at 6 month of follow-up
measure: Patient satisfaction
timeFrame: Six month
measure: Adverse events
timeFrame: Six month
measure: Quality of life
timeFrame: Baseline and at 6 month of follow up
measure: Cost-efficacy evaluation
timeFrame: Six month
measure: Comorbidity index
timeFrame: Six month
measure: Blood pressure
timeFrame: Sixt month
measure: Lost of follow up
timeFrame: Six month
Other outcomes:
measure: Body mass index
timeFrame: Six month
Locations:
city: Lleida
country: Spain
facility: Hospital santa Maria
state: Catalonia
Study officials:
affiliation: Hospital Anrnau Vilanova- Santa Maria, Lleida (Spain)
name: Ferran Barbe, MD
role: STUDY_DIRECTOR
affiliation: Hospital Arnau Vilanova-Santa Maria, Lleida (Spain)
name: Cristina Esquinas, RN, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Primary Care. National Health Institute. Lleida (Spain)
name: Nuria Nadal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sanchez-de-la-Torre M, Nadal N, Cortijo A, Masa JF, Duran-Cantolla J, Valls J, Serra S, Sanchez-de-la-Torre A, Gracia M, Ferrer F, Lorente I, Urgeles MC, Alonso T, Fuentes A, Armengol F, Lumbierres M, Vazquez-Polo FJ, Barbe F; Respiratory Medicine Research Group. Role of primary care in the follow-up of patients with obstructive sleep apnoea undergoing CPAP treatment: a randomised controlled trial. Thorax. 2015 Apr;70(4):346-52. doi: 10.1136/thoraxjnl-2014-206287.