Clinical trial NCT02047071: Effect of CPAP Treatment in Women With Moderate-to-severe OSA.
Official title: Effect of Continuous Positive Airways Pressure (CPAP) in Women With Moderate-to-severe Obstructive Sleep Apnea (OSA). A Multicenter, Randomized, Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive sleep apnea
Female gender
Continuous Positive Airway Pressure
Lead sponsor: Sociedad Española de Neumología y Cirugía Torácica
Sponsor class: OTHER
Collaborators: name: Fondo de Investigacion Sanitaria
name: Sociedad Española de Neumología y Cirugía Torácica
First posted: 2014-01-28
Enrollment: 307
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in quality of life on the Quebec Sleep Questionnaire (QSQ) at week 12
timeFrame: Baseline, 12 weeks.
Secondary outcomes:
measure: Change from baseline in quality of life on the 12-Item Short Form Health Survey (SF-12) at week 12
timeFrame: baseline, 12 weeks
measure: Change from baseline in mood state on the Abbreviated Profile Of Mood States (POMS) at week 12
timeFrame: Baseline, 12 weeks
measure: Change from baseline in sleepiness on the Epworth Sleepiness Score (ESS) at week 12
timeFrame: baseline, 12 weeks
measure: Change from baseline in anxiety and depression on the Hospital Anxiety and Depression questionnaire (HAD) at week 12
timeFrame: baseline, 12 weeks
measure: Change from baseline in quality of life on the Visual Analogic Scale (VAS) at week 12
timeFrame: baseline, 12 weeks
measure: Change from baseline in sleep apnea symptoms at week 12
timeFrame: baseline, 12 weeks
measure: Change from baseline in blood pressure at week 12
timeFrame: Baseline, 12 weeks
measure: Change from baseline in glucose metabolism at week 12
timeFrame: baseline, 12 weeks
measure: Change from baseline in lipid metabolism at week 12
timeFrame: baseline, 12 weeks
Other outcomes:
measure: Number of Participants with CPAP use >= 4 hours/day as a Measure of CPAP adherence
timeFrame: Baseline, 12 weeks
Locations:
city: Seville
country: Spain
facility: Hospital Universitario Valme
Study officials:
affiliation: Sociedad Española de Neumología y Cirugía Torácica
name: Francisco Campos-Rodriguez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Campos-Rodriguez F, Asensio-Cruz MI, Cordero-Guevara J, Jurado-Gamez B, Carmona-Bernal C, Gonzalez-Martinez M, Troncoso MF, Sanchez-Lopez V, Arellano-Orden E, Garcia-Sanchez MI, Martinez-Garcia MA; Spanish Sleep Network. Effect of continuous positive airway pressure on inflammatory, antioxidant, and depression biomarkers in women with obstructive sleep apnea: a randomized controlled trial. Sleep. 2019 Oct 9;42(10):zsz145. doi: 10.1093/sleep/zsz145.
citation: Campos-Rodriguez F, Gonzalez-Martinez M, Sanchez-Armengol A, Jurado-Gamez B, Cordero-Guevara J, Reyes-Nunez N, Troncoso MF, Abad-Fernandez A, Teran-Santos J, Caballero-Rodriguez J, Martin-Romero M, Encabo-Motino A, Sacristan-Bou L, Navarro-Esteva J, Somoza-Gonzalez M, Masa JF, Sanchez-Quiroga MA, Jara-Chinarro B, Orosa-Bertol B, Martinez-Garcia MA; Spanish Sleep Network. Effect of continuous positive airway pressure on blood pressure and metabolic profile in women with sleep apnoea. Eur Respir J. 2017 Aug 10;50(2):1700257. doi: 10.1183/13993003.00257-2017. Print 2017 Aug.
citation: Campos-Rodriguez F, Queipo-Corona C, Carmona-Bernal C, Jurado-Gamez B, Cordero-Guevara J, Reyes-Nunez N, Troncoso-Acevedo F, Abad-Fernandez A, Teran-Santos J, Caballero-Rodriguez J, Martin-Romero M, Encabo-Motino A, Sacristan-Bou L, Navarro-Esteva J, Somoza-Gonzalez M, Masa JF, Sanchez-Quiroga MA, Jara-Chinarro B, Orosa-Bertol B, Martinez-Garcia MA; Spanish Sleep Network. Continuous Positive Airway Pressure Improves Quality of Life in Women with Obstructive Sleep Apnea. A Randomized Controlled Trial. Am J Respir Crit Care Med. 2016 Nov 15;194(10):1286-1294. doi: 10.1164/rccm.201602-0265OC.