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

OSA Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01918449
• Other study ID #: PI12/01499
• Status: Completed
• Phase: N/A
• First received: July 23, 2013
• Last updated: November 24, 2014
• Start date: January 2013
• Est. completion date: June 2014

Study information

• Verified date: November 2014
• Source: Sociedad Española de Neumología y Cirugía Torácica
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: June 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• OSA

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital santa Maria	Lleida	Catalonia

Sponsors (3)

Lead Sponsor	Collaborator
Sociedad Española de Neumología y Cirugía Torácica	Fundacio Catalana de Pneumologia, Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body mass index		Six month	No
Primary	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	No
Secondary	Daytime sleepiness	Epworth Sleepiness Scale (ESS)	At baseline and at 6 month of follow-up	No
Secondary	Patient satisfaction	visual analog scale (0-10)	Six month	No
Secondary	Adverse events	Adverse events related to CPAP treatment	Six month	Yes
Secondary	Quality of life	EuroQol	Baseline and at 6 month of follow up	No
Secondary	Cost-efficacy evaluation	Qualys	Six month	No
Secondary	Comorbidity index	Charlson index	Six month	No
Secondary	Blood pressure	Office blood pressure	Sixt month	No
Secondary	Lost of follow up	Percentage of patients lost during follow up	Six month	No