Effect of CPAP Treatment in Women With Moderate-to-severe OSA.

Obstructive Sleep Apnea Clinical Trial

Official title:

Effect of Continuous Positive Airways Pressure (CPAP) in Women With Moderate-to-severe Obstructive Sleep Apnea (OSA). A Multicenter, Randomized, Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02047071
• Other study ID #: PI13/00743
• Status: Completed
• Phase: N/A
• First received: January 19, 2014
• Last updated: August 17, 2015
• Start date: February 2014
• Est. completion date: July 2015

Study information

• Verified date: August 2015
• Source: Sociedad Española de Neumología y Cirugía Torácica
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether Continuous Positive Airways Pressure (CPAP) improves quality of life, cardiovascular (blood pressure) and metabolic profile (glucose and lipid metabolism) in females with moderate-to-severe Obstructive Sleep Apnea (OSA).

Description:

Study Design: multicenter, open-label, randomized, controlled trial of parallel groups with a final blind evaluation.

Study sites. The following hospitals will participate in the study: Valme (Sevilla), la Fe (Valencia), Virgen del Rocío (Sevilla), Gral Yagüe (Burgos), San Pedro de Alcántara (Cáceres), Dr Peset (Valencia), Severo Ochoa (Madrid), Reina Sofía (Córdoba), Dr Negrín (Las Palmas de Gran Canaria), Virgen de la Victoria (Málaga), Río Hortega (Valladolid), Costa del Sol (Málaga), Marqués de Valdecilla (Santander), Albacete (Albacete), Virgen del Puerto (Cáceres), Puerta de Hierro (Madrid), Consorcio Sanitario de Terrassa (Barcelona), Getafe (Madrid), Gral de Alicante (Alicante), Morales Meseguer (Murcia), Tomelloso (Ciudad Real), and Fundación Jiménez Díaz (Madrid). All centers from Spain.

Methods: consecutive outpatient women aged 18-75 years and referred to the sleep clinics for suspicion of OSA will be studied. They will undergo a diagnostic home respiratory polygraphy, and those diagnosed with moderate-to-severe OSA (AHI ≥15) will be eligible for this study and randomized to optimal CPAP treatment or conservative treatment for 12 weeks. Every women will fulfill a standardized protocol and different quality of life questionnaires. Office blood pressure will be measured. Fasting blood samples will be collected to assess glucose and lipid metabolism. All the measurements will be performed at baseline and after 12 weeks of follow-up. Women will be examined at the time of inclusion, after 4 weeks of follow-up and at the end of follow-up (12 weeks).

149 women with moderate-to-severe OSA need to be enrolled in each study arm, according to the sample size calculated to achieve a clinically significant improvement in the Quebec Sleep Questionnaire. The results will be analyzed both on an intention-to-treat basis and on a per-protocol basis (data only from patients who finish the study and show good adherence to CPAP, defined as an average objective use of at least 4 hours/day).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 307
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Moderate-to-severe OSA (Apnea-Hypopnea index =15) diagnosed by Home Respiratory Polygraphy.

• Age between 18-75 years.

Exclusion Criteria:

• diagnosis of narcolepsy or restless legs syndrome

• unstable cardiovascular profile (cardiovascular event in the previous 3 months)

• cancer or life expectancy lower than 1 year

• uncontrolled psychiatric disorders

• central sleep apnea (>50% of central events)

• pregnancy

• risky jobs and severe hypersomnolence (Epworth >=18) requiring urgent treatment

• either respiratory failure (SaO2<90% or partial oxygen pressure [pO2] <60 mmHg or Long-term O2 therapy

• heart failure (New York Heart Association class III-IV)

• prior CPAP therapy

Study Design

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Continuous positive airways pressure
Optimal Continuous positive airways pressure treatment every night plus standard care for OSA consisting of hygienic-dietary advice and lifestyle counseling.

Locations

Country	Name	City	State
Spain	Hospital Universitario Valme	Seville

Sponsors (3)

Lead Sponsor	Collaborator
Francisco Campos-Rodriguez	Fondo de Investigacion Sanitaria, Sociedad Española de Neumología y Cirugía Torácica

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants with CPAP use >= 4 hours/day as a Measure of CPAP adherence		Baseline, 12 weeks	No
Primary	Change from baseline in quality of life on the Quebec Sleep Questionnaire (QSQ) at week 12		Baseline, 12 weeks.	No
Secondary	Change from baseline in quality of life on the 12-Item Short Form Health Survey (SF-12) at week 12		baseline, 12 weeks	No
Secondary	Change from baseline in mood state on the Abbreviated Profile Of Mood States (POMS) at week 12		Baseline, 12 weeks	No
Secondary	Change from baseline in sleepiness on the Epworth Sleepiness Score (ESS) at week 12		baseline, 12 weeks	No
Secondary	Change from baseline in anxiety and depression on the Hospital Anxiety and Depression questionnaire (HAD) at week 12		baseline, 12 weeks	No
Secondary	Change from baseline in quality of life on the Visual Analogic Scale (VAS) at week 12		baseline, 12 weeks	No
Secondary	Change from baseline in sleep apnea symptoms at week 12		baseline, 12 weeks	No
Secondary	Change from baseline in blood pressure at week 12	Change in office blood pressure from baseline at week 12	Baseline, 12 weeks	No
Secondary	Change from baseline in glucose metabolism at week 12		baseline, 12 weeks	No
Secondary	Change from baseline in lipid metabolism at week 12		baseline, 12 weeks	No