Follow-up of Patients With Obstructive Sleep Apnea in Primary Care.
NCT ID: NCT01918449
Last Updated: 2014-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
210 participants
INTERVENTIONAL
2013-01-31
2014-06-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
No interventions assigned to this group
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.
Clinical follow up by general practitioners in primary care
The study evaluates two different setting to follow up patients with obstructive sleep apnea on CPAP treatment
Interventions
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Clinical follow up by general practitioners in primary care
The study evaluates two different setting to follow up patients with obstructive sleep apnea on CPAP treatment
Eligibility Criteria
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Inclusion Criteria
* Patients with OSA diagnosis performed in the sleep units
* Written informed consent signed.
Exclusion Criteria
* 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).
18 Years
ALL
No
Sponsors
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Instituto de Salud Carlos III
OTHER_GOV
Fundacio Catalana de Pneumologia
OTHER
Sociedad Española de Neumología y Cirugía Torácica
OTHER
Responsible Party
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Ferran Barbe
MD
Principal Investigators
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Ferran Barbe, MD
Role: STUDY_DIRECTOR
Hospital Anrnau Vilanova- Santa Maria, Lleida (Spain)
Cristina Esquinas, RN, MPH
Role: PRINCIPAL_INVESTIGATOR
Hospital Arnau Vilanova-Santa Maria, Lleida (Spain)
Nuria Nadal, MD
Role: PRINCIPAL_INVESTIGATOR
Primary Care. National Health Institute. Lleida (Spain)
Locations
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Hospital santa Maria
Lleida, Catalonia, Spain
Countries
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References
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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.
Other Identifiers
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PI12/01499
Identifier Type: -
Identifier Source: org_study_id