Effect of continuous positive airway pressure treatment of obstructive sleep apnea-hypopnea on fatigue in multiple sclerosis: a randomized, placebo-controlled trial (SAMS-PAP study)
ECTRIMS Online Library. Trojan D. 09/13/19; 279575; 318
Daria Trojan
Daria Trojan
Contributions
Abstract

Abstract: 318

Type: Scientific Session

Abstract Category: RIMS - Symptoms Management (including cognition, fatigue, imbalance)

D. Trojan1, S. Khadadah2, P. Duquette3, V. Jobin4, Y. Lapierre5, A. Benedetti6, F. Johara2, A. Robinson2, E. Roger7, A. Bar-Or8, M. Kaminska9, R.J. Kimoff9

1Montreal Neurological Insitute and Hospital | Neurology and Neurosugery, 2McGill University, 3Department of Neuroscience, 4Pulmonary Service, Department of Medicine, Université de Montréal, 5Department of Neurology and Neurosurgery, 6Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, 7Université de Montréal, Montreal, QC, Canada, 8Department of Neurology, University of Pennsylvania, Philadelphia, PA, United States, 9Respiratory Division, McGill University Health Centre, McGill University, Montreal, QC, Canada

Introduction: We previously reported an improvement of fatigue with obstructive sleep apnea-hypopnea (OSAH) treatment in MS in a non-randomized, controlled study (MSJ 2013;19:480-9).
Objectives and Aims: To conduct a randomized, controlled trial to determine the effect of continuous positive airway pressure (CPAP) treatment on fatigue, sleep quality, somnolence, pain, and disability in MS patients with OSAH.
Methods: We included MS patients with Expanded Disability Status (EDSS) Score ≤7, severe fatigue (Fatigue Severity Score (FSS) ≥4), poor subjective sleep quality (Pittsburgh Sleep Quality Index (PSQI) >5), Montreal Cognitive Assessment score ≥26, and OSAH defined as an apnea-hyopnea index (AHI) ≥15 events/h on in-laboratory polysomnography. Patients with severe OSAH (AHI) >30 and 4% O2 desaturation index >15/h or severe somnolence (Epworth Sleepiness Scale, (ESS) ≥15)) were excluded. Subjects were randomized to 6 months of active vs sham CPAP treatment with assessments at baseline, 3 and 6 months of: FSS (primary outcome), Fatigue Scale of Motor and Cognitive Functions, PSQI, ESS, pain visual analog scale, and EDSS. Objective CPAP compliance was determined from CPAP device memory; per protocol compliance was defined as 4 h/night, 70% of nights. The primary data analysis compared mean changes in outcome measures between the two groups at 6 months with an intention to treat approach.
Results: Of 103 patients screened, 49 met inclusion criteria and were randomized, and 34 randomized subjects completed the protocol. Of these, 12/17(71%) CPAP- and 6/17(35%) sham-treated participants achieved adequate compliance. In a modified intention to treat analysis (n=34), there was a trend to improvement in FSS (0.9±1.0 vs 0.3±0.9, p=0.09) and a significant improvement in ESS (3.4±3.0 vs 0.8±3.4, p=0.03) at 3 months with CPAP compared to sham. We found no significant differences between CPAP vs sham groups in other outcome measures at 3 months, and in fatigue, sleep quality, subjective somnolence, pain, and disability at 6 months.
Conclusions: This study showed a trend to improved fatigue and a significant reduction in somnolence at 3 months of treatment with CPAP compared to sham, but no significant differences in sleep quality, pain and disability. The improvements were not sustained at 6 months of treatment. Further analyses are ongoing to determine the effect of compliance and disease-related variables on study results.
Disclosure: The study was funded by an operating grant from the Multiple Sclerosis Society of Canada. VitalAire, Inc. and Phillips Respironics provided in kind research support for the study. Daria Trojan: receives research support from the Multiple Sclerosis Society of Canada and Grifols Worldwide Operating, Ltd, and in kind research support from VitalAire Inc. and Philips Respironics. Sulaiman Khadadah: nothing to disclose. Pierre Duquette: nothing to disclose. Vincent Jobin: the Sleep Laboratory where he works has received non-restrictive research grants from Biron and Pradair Laboratories. Yves Lapierre: nothing to disclose. Andrea Benedetti: nothing to disclose. Fatema Johara: nothing to disclose. Ann Robinson: nothing to disclose. Elaine Roger: nothing to disclose. Amit Bar-Or: has served on scientific advisory boards for Biogen, F. Hoffmann-La Roche Ltd and Genentech, Inc., GlaxoSmithKline, Guthy-Jackson/GGF, MedImmune, Merck/EMD Serono, Mitsubishi Tanabe, Ono, Receptos and Sanofi-Genzyme and has received research support from Biogen, Novartis and Sanofi-Genzyme. Marta Kaminska: reports consulting and Advisory Committee membership at Biron Soins du Sommeil, unrestricted research support (in-kind ) from Philips Respironics and Air Liquide Canada Ltd. (VitaAire), unrestricted research support from ResMed Corp and Fisher Paykel, and research support from the following non-profit organizations: Canadian Institute of Health Research, and Weston Brain Institute.
R. John Kimoff: receives research operating support from the Multiple Sclerosis Society of Canada, Canadian Insitutes of Health Research, Vitalaire and Philips Respironics.

Abstract: 318

Type: Scientific Session

Abstract Category: RIMS - Symptoms Management (including cognition, fatigue, imbalance)

D. Trojan1, S. Khadadah2, P. Duquette3, V. Jobin4, Y. Lapierre5, A. Benedetti6, F. Johara2, A. Robinson2, E. Roger7, A. Bar-Or8, M. Kaminska9, R.J. Kimoff9

1Montreal Neurological Insitute and Hospital | Neurology and Neurosugery, 2McGill University, 3Department of Neuroscience, 4Pulmonary Service, Department of Medicine, Université de Montréal, 5Department of Neurology and Neurosurgery, 6Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, 7Université de Montréal, Montreal, QC, Canada, 8Department of Neurology, University of Pennsylvania, Philadelphia, PA, United States, 9Respiratory Division, McGill University Health Centre, McGill University, Montreal, QC, Canada

Introduction:
We previously reported an improvement of fatigue with obstructive sleep apnea-hypopnea (OSAH) treatment in MS in a non-randomized, controlled study (MSJ 2013;19:480-9).
Objectives and Aims: To conduct a randomized, controlled trial to determine the effect of continuous positive airway pressure (CPAP) treatment on fatigue, sleep quality, somnolence, pain, and disability in MS patients with OSAH.
Methods: We included MS patients with Expanded Disability Status (EDSS) Score ≤7, severe fatigue (Fatigue Severity Score (FSS) ≥4), poor subjective sleep quality (Pittsburgh Sleep Quality Index (PSQI) >5), Montreal Cognitive Assessment score ≥26, and OSAH defined as an apnea-hyopnea index (AHI) ≥15 events/h on in-laboratory polysomnography. Patients with severe OSAH (AHI) >30 and 4% O2 desaturation index >15/h or severe somnolence (Epworth Sleepiness Scale, (ESS) ≥15)) were excluded. Subjects were randomized to 6 months of active vs sham CPAP treatment with assessments at baseline, 3 and 6 months of: FSS (primary outcome), Fatigue Scale of Motor and Cognitive Functions, PSQI, ESS, pain visual analog scale, and EDSS. Objective CPAP compliance was determined from CPAP device memory; per protocol compliance was defined as 4 h/night, 70% of nights. The primary data analysis compared mean changes in outcome measures between the two groups at 6 months with an intention to treat approach.
Results: Of 103 patients screened, 49 met inclusion criteria and were randomized, and 34 randomized subjects completed the protocol. Of these, 12/17(71%) CPAP- and 6/17(35%) sham-treated participants achieved adequate compliance. In a modified intention to treat analysis (n=34), there was a trend to improvement in FSS (0.9±1.0 vs 0.3±0.9, p=0.09) and a significant improvement in ESS (3.4±3.0 vs 0.8±3.4, p=0.03) at 3 months with CPAP compared to sham. We found no significant differences between CPAP vs sham groups in other outcome measures at 3 months, and in fatigue, sleep quality, subjective somnolence, pain, and disability at 6 months.
Conclusions: This study showed a trend to improved fatigue and a significant reduction in somnolence at 3 months of treatment with CPAP compared to sham, but no significant differences in sleep quality, pain and disability. The improvements were not sustained at 6 months of treatment. Further analyses are ongoing to determine the effect of compliance and disease-related variables on study results.
Disclosure: The study was funded by an operating grant from the Multiple Sclerosis Society of Canada. VitalAire, Inc. and Phillips Respironics provided in kind research support for the study. Daria Trojan: receives research support from the Multiple Sclerosis Society of Canada and Grifols Worldwide Operating, Ltd, and in kind research support from VitalAire Inc. and Philips Respironics. Sulaiman Khadadah: nothing to disclose. Pierre Duquette: nothing to disclose. Vincent Jobin: the Sleep Laboratory where he works has received non-restrictive research grants from Biron and Pradair Laboratories. Yves Lapierre: nothing to disclose. Andrea Benedetti: nothing to disclose. Fatema Johara: nothing to disclose. Ann Robinson: nothing to disclose. Elaine Roger: nothing to disclose. Amit Bar-Or: has served on scientific advisory boards for Biogen, F. Hoffmann-La Roche Ltd and Genentech, Inc., GlaxoSmithKline, Guthy-Jackson/GGF, MedImmune, Merck/EMD Serono, Mitsubishi Tanabe, Ono, Receptos and Sanofi-Genzyme and has received research support from Biogen, Novartis and Sanofi-Genzyme. Marta Kaminska: reports consulting and Advisory Committee membership at Biron Soins du Sommeil, unrestricted research support (in-kind ) from Philips Respironics and Air Liquide Canada Ltd. (VitaAire), unrestricted research support from ResMed Corp and Fisher Paykel, and research support from the following non-profit organizations: Canadian Institute of Health Research, and Weston Brain Institute.
R. John Kimoff: receives research operating support from the Multiple Sclerosis Society of Canada, Canadian Insitutes of Health Research, Vitalaire and Philips Respironics.

By clicking “Accept Terms & all Cookies” or by continuing to browse, you agree to the storing of third-party cookies on your device to enhance your user experience and agree to the user terms and conditions of this learning management system (LMS).

Cookie Settings
Accept Terms & all Cookies