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Positive Predictive Value of the SAMSPAP (Sleep Apnea in Multiple Sclerosis Positive Airway Pressure) Trial Eligibility Criteria for Sleep Apnea Diagnosis
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A2413 - Positive Predictive Value of the SAMSPAP (Sleep Apnea in Multiple Sclerosis Positive Airway Pressure) Trial Eligibility Criteria for Sleep Apnea Diagnosis
Author Block: S. M. Khadadah1, D. Trojan2, P. Duquette3, V. Jobin3, Y. Lapierre2, A. Benedetti4, A. Robinson2, E. Roger3, A. Bar-Or2, M. Kaminska1, R. J. Kimoff1; 1Respiratory Division, McGill University Health Centre, Montreal, QC, Canada, 2Department of Neurology and Neurosurgery, Montreal Neurological Institute and Hospital, McGill University Health Centre, montreal, QC, Canada, 3Centre Hospitalier de l'Université de Montréal, montreal, QC, Canada, 4Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, QC, Canada.
Introduction:
A relationship between severe fatigue and obstructive sleep apnea (OSA) in multiple sclerosis (MS) patients has been previously described by our group (Mult. Scler. J. Vol 18; 1159 - 1169). We are currently conducting a randomized, controlled trial (SAMSPAP, NCT01746342) evaluating the effects of PAP treatment of OSA on fatigue and other clinical symptoms in MS patients. The aim of this present analysis was to assess the positive predictive value of our clinical eligibility criteria for this trial to identify OSA in MS patients.
Methods:
Confirmed MS patients on stable immunomodulating medication presenting to our institution’s MS clinics were recruited. The clinical eligibility criteria are: severe fatigue (Fatigue Severity Scale (FSS) score ≥ 4), poor subjective sleep quality (Pittsburgh Sleep Quality Index (PSQI) >5), no more than minimal cognitive impairment (Montreal Cognitive Assessment (MoCA) ≥26) and Expanded Disability Status Scale score (EDSS) ≤7. An Apnea-Hypopnea Index (AHI) of ≥ 15 events/h on complete overnight polysomnography (PSG) scored using AASM research (Chicago) criteria defined OSA.
Results:
In the initial screening visit 93 subjects (34% male) were evaluated. 79 (85%) of these subjects met the clinical eligibility criteria and underwent PSG. Reasons for exclusion after screening included (n); withdrawal before completing screening (4); low FSS (5); low MoCA (5); and low PSQI (1). Subjects undergoing PSG were of mean(±SD) age=49±9 y, BMI=29±6 kg/m2, EDSS=3±2, MoCA=28±1, FSS=6±1, Epworth Sleepiness score (ESS)=9±5 and PSQI=11±4. On PSG they had a total sleep time=5.5±1.1h, AHI=30±22/h, 4% Oxygen Desaturation Index (ODI) =6±10/h and Central apnea index = 1±2/h. 58 of 79 subjects met criteria for OSA (mean AHI = 37±21/h, ODI 6±9, respiratory arousal index =34±20/h). Nine of these 58 subjects surpassed our pre-specified OSA safety threshold for randomization to this 6-month, sham PAP-controlled trial (AHI > 30 with either 4% ODI>15/h (n=8) or ESS ≥ 15 (n=1)). The positive predictive value for OSA of our clinical eligibility criteria was 73% (95%CI 61-83%), and for severe OSA (AHI >30/h) was 40% (95%CI 29-53%).
Conclusion:
The high positive predictive value of our study eligibility criteria indicates that OSA should be considered among ambulatory MS patients presenting with severe fatigue and poor subjective sleep quality. Our ongoing SAMSPAP trial will provide new insights on the efficacy of OSA treatment on severe fatigue in MS patients.
Author Block: S. M. Khadadah1, D. Trojan2, P. Duquette3, V. Jobin3, Y. Lapierre2, A. Benedetti4, A. Robinson2, E. Roger3, A. Bar-Or2, M. Kaminska1, R. J. Kimoff1; 1Respiratory Division, McGill University Health Centre, Montreal, QC, Canada, 2Department of Neurology and Neurosurgery, Montreal Neurological Institute and Hospital, McGill University Health Centre, montreal, QC, Canada, 3Centre Hospitalier de l'Université de Montréal, montreal, QC, Canada, 4Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, QC, Canada.
Introduction:
A relationship between severe fatigue and obstructive sleep apnea (OSA) in multiple sclerosis (MS) patients has been previously described by our group (Mult. Scler. J. Vol 18; 1159 - 1169). We are currently conducting a randomized, controlled trial (SAMSPAP, NCT01746342) evaluating the effects of PAP treatment of OSA on fatigue and other clinical symptoms in MS patients. The aim of this present analysis was to assess the positive predictive value of our clinical eligibility criteria for this trial to identify OSA in MS patients.
Methods:
Confirmed MS patients on stable immunomodulating medication presenting to our institution’s MS clinics were recruited. The clinical eligibility criteria are: severe fatigue (Fatigue Severity Scale (FSS) score ≥ 4), poor subjective sleep quality (Pittsburgh Sleep Quality Index (PSQI) >5), no more than minimal cognitive impairment (Montreal Cognitive Assessment (MoCA) ≥26) and Expanded Disability Status Scale score (EDSS) ≤7. An Apnea-Hypopnea Index (AHI) of ≥ 15 events/h on complete overnight polysomnography (PSG) scored using AASM research (Chicago) criteria defined OSA.
Results:
In the initial screening visit 93 subjects (34% male) were evaluated. 79 (85%) of these subjects met the clinical eligibility criteria and underwent PSG. Reasons for exclusion after screening included (n); withdrawal before completing screening (4); low FSS (5); low MoCA (5); and low PSQI (1). Subjects undergoing PSG were of mean(±SD) age=49±9 y, BMI=29±6 kg/m2, EDSS=3±2, MoCA=28±1, FSS=6±1, Epworth Sleepiness score (ESS)=9±5 and PSQI=11±4. On PSG they had a total sleep time=5.5±1.1h, AHI=30±22/h, 4% Oxygen Desaturation Index (ODI) =6±10/h and Central apnea index = 1±2/h. 58 of 79 subjects met criteria for OSA (mean AHI = 37±21/h, ODI 6±9, respiratory arousal index =34±20/h). Nine of these 58 subjects surpassed our pre-specified OSA safety threshold for randomization to this 6-month, sham PAP-controlled trial (AHI > 30 with either 4% ODI>15/h (n=8) or ESS ≥ 15 (n=1)). The positive predictive value for OSA of our clinical eligibility criteria was 73% (95%CI 61-83%), and for severe OSA (AHI >30/h) was 40% (95%CI 29-53%).
Conclusion:
The high positive predictive value of our study eligibility criteria indicates that OSA should be considered among ambulatory MS patients presenting with severe fatigue and poor subjective sleep quality. Our ongoing SAMSPAP trial will provide new insights on the efficacy of OSA treatment on severe fatigue in MS patients.
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