Francisco Campos-Rodriguez1, Carlos Queipo-Corona2, Carmen Carmona-Bernal3, Bernabe Jurado-Gamez4, Jose Cordero-Guevara5, Nuria Reyes-Nuñez1, Fernanda Troncoso-Acevedo6, Araceli Abad-Fernandez7, Joaquin Teran-Santos8,9, Julian Caballero-Rodriguez10, Mercedes Martin-Romero11, Ana Encabo-Motiño12, Lirios Sacristan-Bou13, Javier Navarro-Esteva14, Maria Somoza-Gonzalez15, Juan F Masa9,16, Maria A Sanchez-Quiroga17, Beatriz Jara-Chinarro18, Belen Orosa-Bertol19, Miguel A Martinez-Garcia9,20. 1. 1 Respiratory Department, Hospital Universitario de Valme, Sevilla, Spain. 2. 2 Respiratory Department, Hospital Universitario Marques de Valdecilla, Santander, Spain. 3. 3 Medical-Surgical Unit of Respiratory Diseases, Virgen del Rocio University Hospital, Sevilla, Spain. 4. 4 Department of Respiratory Medicine, Reina Sofia University Hospital, Institute of Biomedical Research Maimonides (IMIBIC), University of Cordoba, Cordoba, Spain. 5. 5 Gerencia de Atención Primaria de Burgos, Burgos, Spain. 6. 6 Respiratory Department, Fundación Jimenez Diaz, Madrid, Spain. 7. 7 Respiratory Department, Hospital Universitario de Getafe, Madrid, Spain. 8. 8 Respiratory Department, Hospital Universitario de Burgos, Burgos, Spain. 9. 9 Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain. 10. 10 Respiratory Department, Hospital Morales Meseguer, Murcia, Spain. 11. 11 Respiratory Department, Hospital Universitario Virgen de la Victoria, Malaga, Spain. 12. 12 Respiratory Department, Hospital Severo Ochoa, Madrid, Spain. 13. 13 Respiratory Department, Hospital General de Tomelloso, Ciudad Real, Spain. 14. 14 Respiratory Department, Hospital Universitario de Gran Canaria Doctor Negrín, Las Palmas de Gran Canaria, Spain. 15. 15 Respiratory Department, Consorcio Sanitario de Terrassa, Barcelona, Spain. 16. 16 Respiratory Department, Hospital San Pedro de Alcantara, Caceres, Spain. 17. 17 Respiratory Department, Hospital Virgen del Puerto, Caceres, Spain. 18. 18 Respiratory Department, Hospital Puerta de Hierro, Madrid, Spain. 19. 19 Respiratory Department, Hospital Universitario Doctor Peset, Valencia, Spain; and. 20. 20 Respiratory Department, Hospital Universitario y Politecnico La Fe, Valencia, Spain.
Abstract
RATIONALE: Continuous positive airway pressure (CPAP) is the treatment of choice in patients with symptomatic obstructive sleep apnea (OSA). CPAP treatment improves quality of life (QoL) in men with OSA, but its role in women has not yet been assessed. OBJECTIVES: To investigate the effect of CPAP on QoL in women with moderate to severe OSA. METHODS: We conducted a multicenter, open-label randomized controlled trial in 307 consecutive women diagnosed with moderate to severe OSA (apnea-hypopnea index, ≥15) in 19 Spanish sleep units. Women were randomized to receive effective CPAP therapy (n = 151) or conservative treatment (n = 156) for 3 months. The primary endpoint was the change in QoL based on the Quebec Sleep Questionnaire. Secondary endpoints included changes in daytime sleepiness, mood state, anxiety, and depression. Data were analyzed on an intention-to-treat basis with adjustment for baseline values and other relevant clinical variables. MEASUREMENTS AND MAIN RESULTS: The women in the study had a mean (SD) age of 57.1 (10.1) years and a mean (SD) Epworth Sleepiness Scale score of 9.8 (4.4), and 77.5% were postmenopausal. Compared with the control group, the CPAP group achieved a significantly greater improvement in all QoL domains of the Quebec Sleep Questionnaire (adjusted treatment effect between 0.53 and 1.33; P < 0.001 for all domains), daytime sleepiness (-2.92; P < 0.001), mood state (-4.24; P = 0.012), anxiety (-0.89; P = 0.014), depression (-0.85; P = 0.016), and the physical component summary of the 12-item Short Form Health Survey (2.78; P = 0.003). CONCLUSIONS: In women with moderate or severe OSA, 3 months of CPAP therapy improved QoL, mood state, anxiety and depressive symptoms, and daytime sleepiness compared with conservative treatment. Clinical trial registered with www.clinicaltrials.gov (NCT02047071).
RCT Entities:
RATIONALE: Continuous positive airway pressure (CPAP) is the treatment of choice in patients with symptomatic obstructive sleep apnea (OSA). CPAP treatment improves quality of life (QoL) in men with OSA, but its role in women has not yet been assessed. OBJECTIVES: To investigate the effect of CPAP on QoL in women with moderate to severe OSA. METHODS: We conducted a multicenter, open-label randomized controlled trial in 307 consecutive women diagnosed with moderate to severe OSA (apnea-hypopnea index, ≥15) in 19 Spanish sleep units. Women were randomized to receive effective CPAP therapy (n = 151) or conservative treatment (n = 156) for 3 months. The primary endpoint was the change in QoL based on the Quebec Sleep Questionnaire. Secondary endpoints included changes in daytime sleepiness, mood state, anxiety, and depression. Data were analyzed on an intention-to-treat basis with adjustment for baseline values and other relevant clinical variables. MEASUREMENTS AND MAIN RESULTS: The women in the study had a mean (SD) age of 57.1 (10.1) years and a mean (SD) Epworth Sleepiness Scale score of 9.8 (4.4), and 77.5% were postmenopausal. Compared with the control group, the CPAP group achieved a significantly greater improvement in all QoL domains of the Quebec Sleep Questionnaire (adjusted treatment effect between 0.53 and 1.33; P < 0.001 for all domains), daytime sleepiness (-2.92; P < 0.001), mood state (-4.24; P = 0.012), anxiety (-0.89; P = 0.014), depression (-0.85; P = 0.016), and the physical component summary of the 12-item Short Form Health Survey (2.78; P = 0.003). CONCLUSIONS: In women with moderate or severe OSA, 3 months of CPAP therapy improved QoL, mood state, anxiety and depressive symptoms, and daytime sleepiness compared with conservative treatment. Clinical trial registered with www.clinicaltrials.gov (NCT02047071).
Entities:
Keywords:
Quebec Sleep Questionnaire; continuous positive airway pressure; obstructive sleep apnea; quality of life; women
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