Follow-up of Patients With Obstructive Sleep Apnea in Primary Care.

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.

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 Overview

• Status: Completed
• Conditions: OSA
• Intervention / Treatment: Other: Clinical follow up by general practitioners in primary care

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Catalonia
    • Lleida, Catalonia, Spain, 25198
      • Hospital Santa Maria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of hours of use per day of CPAP	Number of hours of use per day of CPAP according to the internal clock of the CPAP device	Six month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daytime sleepiness	Epworth Sleepiness Scale (ESS)	At baseline and at 6 month of follow-up
Patient satisfaction	visual analog scale (0-10)	Six month
Adverse events	Adverse events related to CPAP treatment	Six month
Quality of life	EuroQol	Baseline and at 6 month of follow up
Cost-efficacy evaluation	Qualys	Six month
Comorbidity index	Charlson index	Six month
Blood pressure	Office blood pressure	Sixt month
Lost of follow up	Percentage of patients lost during follow up	Six month

Other Outcome Measures

Outcome Measure	Time Frame
Body mass index	Six month

Collaborators and Investigators

• Sponsor: Sociedad Española de Neumología y Cirugía Torácica
• Collaborators: Fundacio Catalana de Pneumologia; Instituto de Salud Carlos III
• Investigators: Study Director: Ferran Barbe, MD, Hospital Anrnau Vilanova- Santa Maria, Lleida (Spain); Principal Investigator: Cristina Esquinas, RN, MPH, Hospital Arnau Vilanova-Santa Maria, Lleida (Spain); Principal Investigator: Nuria Nadal, MD, Primary Care. National Health Institute. Lleida (Spain)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: July 23, 2013
• First Submitted That Met QC Criteria: August 5, 2013
• First Posted (Estimate): August 7, 2013

Study Record Updates

• Last Update Posted (Estimate): November 25, 2014
• Last Update Submitted That Met QC Criteria: November 24, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: OSA; primary care; efficacy; CPAP treatment
• Other Study ID Numbers: PI12/01499