Treatment with Continuous Positive Airway Pressure Is Not Effective in Patients with Sleep Apnea but No Daytime Sleepiness

A Randomized, Controlled Trial

  1. Ferran Barbé, MD;
  2. Lola R. Mayoralas, PhD;
  3. Joaquin Duran, MD;
  4. Juan F. Masa, MD;
  5. Andreu Maimó, MD;
  6. Josep M. Montserrat, MD;
  7. Carmen Monasterio, MD;
  8. Margalida Bosch, RN;
  9. Antoni Ladaria, MD;
  10. Manuela Rubio, MD;
  11. Ramon Rubio, MD;
  12. Magdalena Medinas, PhD;
  13. Lourdes Hernandez, MD;
  14. Silvia Vidal, MD;
  15. Neil J. Douglas, MD; and
  16. Alvar G.N. Agustí, MD
  1. From Hospital Universitari Son Dureta, Palma de Mallorca, Hospital San Pedro de Alcantara, Caceres, Hospital Txagorritxu, Vitoria-Gasteiz, Hospital Joan March, Bunyola, Hospital Clinic, Barcelona, and Hospital Bellvitge, L'Hospitalet de Llobregat, Spain; and Royal Infirmary, Edinburgh, United Kingdom.

    Abstract

    Background: The sleep apnea–hypopnea syndrome is defined by a pathologic number of respiratory events during sleep (the apnea–hypopnea index, defined as the number of apnea and hypopnea episodes per hour) and daytime symptoms (mostly, excessive sleepiness). In patients with the sleep apnea syndrome, treatment with continuous positive airway pressure (CPAP) normalizes both the apnea–hypopnea index and diurnal symptoms. However, the effect of CPAP in persons with a pathologic apnea–hypopnea index without daytime sleepiness is unclear.

    Objective: To investigate the short-term effects of CPAP on quality of life, objective sleepiness, cognitive function, and arterial blood pressure in nonsleepy patients with a pathologic apnea–hypopnea index.

    Design: Multicenter randomized, placebo-controlled, parallel-group study.

    Setting: Six teaching hospitals in Spain.

    Patients: 55 patients with an apnea–hypopnea index of 30 or greater who did not have daytime sleepiness (Epworth Sleepiness Scale score ≤ 10).

    Intervention: Patients were randomly assigned to receive optimal (n = 29) or sham (n = 25) CPAP and were observed for 6 weeks.

    Measurements: Quality of life, objective sleepiness (Multiple Sleep Latency Test score), cognitive function, and arterial blood pressure.

    Results: The intervention and control groups were similar in terms of mean (±SE) age (54 ± 2 vs. 52 ± 2 years), apnea–hypopnea index (54 ± 3 vs. 57 ± 4), Epworth Sleepiness Scale score (7.0 ± 0.4 vs. 7.0 ± 0.4) and adherence to CPAP treatment (5.0 ± 0.4 vs. 4.0 ± 0.5 hours/d). Other variables, such as quality of life, cognitive function, and arterial blood pressure, were also similar in both groups before treatment. After 6 weeks of CPAP or sham CPAP, none of these variables changed significantly.

    Conclusion: In patients with an apnea–hypopnea index of 30 or greater and no subjective daytime sleepiness, CPAP does not modify quality of life, objective sleepiness, vigilance, attention, memory, information processing, visuomotor coordination, or arterial blood pressure. Treatment with CPAP is therefore not indicated in nonsleepy patients with a pathologic apnea–hypopnea index.

    Article and Author Information

    • Acknowledgments: The authors thank the participating patients; Jordi Forteza-Rey, MD (Hospital Universitari Son Dureta, de Palma de Mallorca, Spain), for help with the ambulatory blood pressure monitoring system; and A. De la Peña, MD (Unidad de Apoyo a la Investigación, Hospital Universitari Son Dureta), and Gemma Vilagut, PhD (Institut Municipal de Investigació Médica, Barcelona), for advice on statistical analysis.

    • Grant Support: In part by Fondo Investigacion Sanitaria grant 99-0032, the Spanish Respiratory Society (1998), and Associacio Balear per l'estudi de les malaties respiratories.

    • Requests for Single Reprints: Alvar G.N. Agustí, MD, Servei de Pneumologia, Hospital Universitari Son Dureta, Andrea Doria, 55, 07014 Palma de Mallorca, Spain; e-mail, aagusti{at}hsd.es.

    • Current Author Addresses: Dr. Barbé, Dr. Mayoralas, Ms. Bosch, Dr. Ladaria, and Dr. Agustí: Servei de Pneumologia, Hospital Universitari Son Dureta, Andrea Doria, 55, 07014 Palma de Mallorca, Spain.

    • Drs. Duran and R. Rubio: Servicio de Neumologia, Hospital Txagorritxu, 01009 Vitoria-Gasteiz, Spain.

    • Drs. Masa and M. Rubio: Servicio de Neumologia, Hospital San Pedro de Alcantara, 10003 Caceres, Spain.

    • Drs. Maimó and Medinas: Hospital Joan March, Servei de Pneumologia, Carretera de Soller, 15, 07193 Bunyola. Spain.

    • Drs. Montserrat and Hernandez: Servei de Pneumologia, Hospital Clinic, Villarroel, 170, 08036 Barcelona, Spain.

    • Drs. Monasterio and Vidal: Servei de Pneumologia, Hospital de Bellvitge, 08970 L'Hospitalet de Llobregat, Spain.

    • Dr. Douglas: Respiratory Medicine Unit, Department of Medicine, The University of Edinburgh, Royal Infirmary, Edinburgh EH3 9YW, United Kingdom.

    • Author Contributions: Conception and design: F. Barbé, L.R. Mayoralas, J. Duran, J.F. Masa, A. Maimó, J.M. Montserrat, C. Monasterio, R. Rubio, L. Hernandez, S. Vidal, N.J. Douglas, A.G.N. Agustí.

    • Analysis and interpretation of the data: F. Barbé, L.R. Mayoralas, J. Duran, J.M. Montserrat, M. Bosch, R. Rubio, L. Hernandez, N.J. Douglas, A.G.N. Agustí.

    • Drafting of the article: F. Barbé, L.R. Mayoralas, M. Bosch, A.G.N. Agustí.

    • Critical revision of the article for important intellectual content: J. Duran, J.F. Masa, A. Maimó, J.M. Montserrat, C. Monasterio, M. Rubio, L. Hernandez, S. Vidal, N.J. Douglas.

    • Final approval of the article: F. Barbé, L.R. Mayoralas, J. Duran, J.F. Masa, A. Maimó, J.M. Montserrat, C. Monasterio, M. Bosch, A. Ladaria, M. Rubio, R. Rubio, M. Medinas, L. Hernandez, S. Vidal, N.J. Douglas, A.G.N. Agustí.

    • Provision of study materials or patients: F. Barbé, L.R. Mayoralas, J. Duran, J.F. Masa, A. Maimó, J.M. Montserrat, C. Monasterio, M. Bosch, A. Ladaria, M. Rubio, R. Rubio, M. Medinas, L. Hernandez, S. Vidal.

    • Statistical expertise: A.G.N. Agustí.

    • Obtaining of funding: F. Barbé, J. Duran, J.F. Masa, A. Maimó, J.M. Montserrat, M. Rubio, R. Rubio, A.G.N. Agustí.

    • Administrative, technical, or logistic support: L.R. Mayoralas, A. Maimó, J.M. Montserrat, C. Monasterio, M. Bosch, A. Ladaria, M. Rubio, M. Medinas, L. Hernandez, S. Vidal.

    • Collection and assembly of data: L.R. Mayoralas, M. Bosch, A. Ladaria, M. Rubio.

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    1. Ann Intern Med June 5, 2001 vol. 134 no. 11 1015-1023
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