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

NCT01918449 | Completed

• 1 other identifier: PI12/01499
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

OSA

Keywords

OSA; CPAP treatment; primary care; efficacy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Daytime sleepiness

  At baseline and at 6 month of follow-up

• Patient satisfaction

  Six month

• Adverse events

  Six month

• Quality of life

  Baseline and at 6 month of follow up

• Cost-efficacy evaluation

  Six month

Other Outcomes (1)

• Body mass index

  Six month

Study Arms (2)

Sleep Unit group

NO INTERVENTION

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

EXPERIMENTAL

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

Interventions

Clinical follow up by general practitioners in primary care OTHER

The study evaluates two different setting to follow up patients with obstructive sleep apnea on CPAP treatment

Primary Care group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women over 18 years old.
• Patients with OSA diagnosis performed in the sleep units
• Written informed consent signed.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sociedad Española de Neumología y Cirugía Torácica: lead
• Instituto de Salud Carlos III: collaborator
• Fundacio Catalana de Pneumologia: collaborator

Study Sites (1)

Hospital santa Maria

Lleida, Catalonia, 25198, Spain

Location

Related Publications (1)

• 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.

  PMID: 25766689 DERIVED

MeSH Terms

Interventions

Primary Health Care

Intervention Hierarchy (Ancestors)

Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Ferran Barbe, MD

  Hospital Anrnau Vilanova- Santa Maria, Lleida (Spain)

  STUDY DIRECTOR

• Cristina Esquinas, RN, MPH

  Hospital Arnau Vilanova-Santa Maria, Lleida (Spain)

  PRINCIPAL INVESTIGATOR

• Nuria Nadal, MD

  Primary Care. National Health Institute. Lleida (Spain)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 23, 2013
• First Posted: August 7, 2013
• Study Start: January 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2014
• Last Updated: November 25, 2014

Record last verified: 2014-11

Locations

ES (1)