STUDY OBJECTIVES:Obstructive sleep apnea (OSA) is an independent risk factor for stroke. The objective of this study was to assess the effect of continuous positive airway pressure (CPAP) treatment on prevention of new vascular events among patients with stroke and OSA. METHODS:Consecutive conscious patients presenting with first imaging-confirmed arterial stroke were included, 6 weeks or more after ictus. All patients underwent clinical and polysomnography (PSG) testing. Patients with an apnea-hypopnea index (AHI) of > 15 events/h were randomized to posttitration nightly CPAP treatment and non-CPAP (received best medical treatment) groups. On follow-up at 3, 6, and 12 months from randomization, evaluation was carried out for any new vascular events as the primary outcome measure, and for clinical stroke outcomes (using the Barthel Index and modified Rankin scale) and neuropsychological parameters as the secondary outcome measures. RESULTS: Among the 679 patients with stroke who were screened, 116 reported for PSG, 83 had AHI > 15 events/h, and 70 (34 in CPAP and 36 in non-CPAP) were randomized. Thirteen patients could not be randomized because of a lack of CPAP devices. Four patients crossed over from the CPAP to the non-CPAP group. Age (mean age 53.41 ± 9.85 in CPAP versus 52.69 ± 13.23 years in non-CPAP, P = .81) and sex distribution (24 males in CPAP versus 33 males in non-CPAP, P = .79) were similar in both groups. At 12-month follow-up, there was 1 vascular event (3.33%) in the CPAP group and 6 events (15%) in the non-CPAP group (P = .23). Modified Rankin scale score improvement by ≥ 1 at 12-month follow-up was found in significantly more patients in the CPAP group than in the non-CPAP group (53% versus 27%). CONCLUSIONS: These findings suggest significantly better stroke outcomes and statistically nonsignificant favorable outcomes in terms of recurrence of vascular events for patients with stroke and OSA who use CPAP treatment. CLINICAL TRIAL REGISTRATION: Registry: Clinical Trials Registry - India, CTRI Registration No: CTRI/2016/07.007104, Title: Sleep Disordered Breathing in stroke patients: Effect of treatment trial, URL: http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=8682&EncHid=&userName=sleep%20disordered%20breathing.
RCT Entities:
STUDY OBJECTIVES: Obstructive sleep apnea (OSA) is an independent risk factor for stroke. The objective of this study was to assess the effect of continuous positive airway pressure (CPAP) treatment on prevention of new vascular events among patients with stroke and OSA. METHODS: Consecutive conscious patients presenting with first imaging-confirmed arterial stroke were included, 6 weeks or more after ictus. All patients underwent clinical and polysomnography (PSG) testing. Patients with an apnea-hypopnea index (AHI) of > 15 events/h were randomized to posttitration nightly CPAP treatment and non-CPAP (received best medical treatment) groups. On follow-up at 3, 6, and 12 months from randomization, evaluation was carried out for any new vascular events as the primary outcome measure, and for clinical stroke outcomes (using the Barthel Index and modified Rankin scale) and neuropsychological parameters as the secondary outcome measures. RESULTS: Among the 679 patients with stroke who were screened, 116 reported for PSG, 83 had AHI > 15 events/h, and 70 (34 in CPAP and 36 in non-CPAP) were randomized. Thirteen patients could not be randomized because of a lack of CPAP devices. Four patients crossed over from the CPAP to the non-CPAP group. Age (mean age 53.41 ± 9.85 in CPAP versus 52.69 ± 13.23 years in non-CPAP, P = .81) and sex distribution (24 males in CPAP versus 33 males in non-CPAP, P = .79) were similar in both groups. At 12-month follow-up, there was 1 vascular event (3.33%) in the CPAP group and 6 events (15%) in the non-CPAP group (P = .23). Modified Rankin scale score improvement by ≥ 1 at 12-month follow-up was found in significantly more patients in the CPAP group than in the non-CPAP group (53% versus 27%). CONCLUSIONS: These findings suggest significantly better stroke outcomes and statistically nonsignificant favorable outcomes in terms of recurrence of vascular events for patients with stroke and OSA who use CPAP treatment. CLINICAL TRIAL REGISTRATION: Registry: Clinical Trials Registry - India, CTRI Registration No: CTRI/2016/07.007104, Title: Sleep Disordered Breathing in strokepatients: Effect of treatment trial, URL: http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=8682&EncHid=&userName=sleep%20disordered%20breathing.
Authors: Susan Redline; Gayane Yenokyan; Daniel J Gottlieb; Eyal Shahar; George T O'Connor; Helaine E Resnick; Marie Diener-West; Mark H Sanders; Philip A Wolf; Estella M Geraghty; Tauqeer Ali; Michael Lebowitz; Naresh M Punjabi Journal: Am J Respir Crit Care Med Date: 2010-03-25 Impact factor: 21.405
Authors: Lianne M Tomfohr; Thomas Hemmen; Loki Natarajan; Sonia Ancoli-Israel; Jose S Loredo; Robert K Heaton; Wayne Bardwell; Paul J Mills; Roland R Lee; Joel E Dimsdale Journal: Stroke Date: 2012-09-27 Impact factor: 7.914
Authors: Clete A Kushida; Alejandro Chediak; Richard B Berry; Lee K Brown; David Gozal; Conrad Iber; Sairam Parthasarathy; Stuart F Quan; James A Rowley Journal: J Clin Sleep Med Date: 2008-04-15 Impact factor: 4.062
Authors: Nancy A Collop; W McDowell Anderson; Brian Boehlecke; David Claman; Rochelle Goldberg; Daniel J Gottlieb; David Hudgel; Michael Sateia; Richard Schwab Journal: J Clin Sleep Med Date: 2007-12-15 Impact factor: 4.062