Dermatology & Plastic Surgery Institute Outcomes
Sleep Disorders
Hypersomnia
As part of comprehensive care for patients with hypersomnia, the Cleveland Clinic Sleep Disorders Center offered clinical trials for patients with narcolepsy and idiopathic hypersomnia and investigators have contributed to numerous publications on new therapeutics for hypersomnia disorders. Highlights include:
- TAK-861 - a novel compound under investigation for the treatment of narcolepsy that acts by targeting the orexin receptor type 2. Narcolepsy type 1 is believed to be caused by an autoimmune destruction of orexin secreting neurons in the hypothalamus.
- JAZZ JZP258-407 - open label study evaluating low -sodium oxybate on sleepiness, polysomnography, and functional outcomes in adults with narcolepsy or idiopathic hypersomnia. While low-sodium oxybate is approved for the treatment of narcolepsy and idiopathic hypersomnia, prior studies did not investigate multiple daytime symptoms and functional impacts or sleep architecture in these disorders.
- SUVN-G3031 - randomized controlled trial studying the safety, tolerability, pharmacokinetics, and efficacy of Samelisant, a selective histamine-3 receptor inverse agonist in patients with narcolepsy with or without cataplexy.
Hypersomnia
2023
2276 Hypersomnia patients had at least 2 visits in 2023 with ESS data available for analysis. Among those patients whose baseline ESS score ≥10 (N=1269), 36.5% (N=464), improved, 52.2% (N=662) remained stable, and 11.3% (N=143) worsened. Median duration of follow-up was 128 days (range, 1-351). Clinically meaningful change was defined as a total score change of 3, based on one-half the standard deviation.¹
3608 Hypersomnia patients had at least 2 visits in 2023 with PHQ-0 data available for analysis. Among those patients whose baseline PHQ-9 score ≥10 (N=1387), 34.3% (N=476) improved, 58.1% (N=806) remained stable, and 7.6% (N=105) worsened. Median duration of follow up was 194 days (range, 1-360). Clinically meaningful change was defined as a total score change of 5, based on one-half the standard deviation.¹
2769 Hypersomnia patients had at least 2 visits in 2023 with PROMIS Mental Health data available for analysis. Among those patients whose baseline PROMIS Mental Health score ≤45 (N=1478), 23.3% (N=344) improved, 65.4% (N=967) remained stable, and 11.3% (N=167) worsened. Median duration of follow-up was 208 days (range, 1-359). Clinically meaningful change was defined as a 5-unit change in T-score, based on one-half the standard deviation.¹
2774 Hypersomnia patients had at least 2 visits in 2023 with PROMIS Physical Health data available for analysis. Among those patients whose baseline PROMIS Physical Health score ≤45 (N=1691), 24.9% (N=421) improved, 64.6% (N=1093) remained stable, and 10.5% (N=177) worsened. Median duration of follow-up was 210 days (range, 1-359). Clinically meaningful change was defined as a 5-unit change in T-score, based on one-half the standard deviation.¹
2753 Hypersomnia patients had at least 2 visits in 2023 with PROMIS Sleep Disturbance data available for analysis. Among those patients whose baseline PROMIS Sleep Disturbance score ≥55 (N=1626), 41.1% (N=669) improved, 50.8% (N=826) remained stable, and 8.1% (N=131) worsened. Median duration of follow-up was 130 days (range, 1-359). Clinically meaningful change was defined as a 5-unit change in T-score, based on one-half the standard deviation.¹
885 Hypersomnia patients had at least 2 visits in 2023 with Sleep Time data available for analysis. Among those patients who self-reported a baseline Sleep Time ≤24 hours (N=885), 25.1% (N=222 ) improved, 53.1% (N=470) remained stable, and 21.8% (N=193) worsened. Median duration of follow-up was 194 days (range, 1-351 days). Clinically meaningful change was defined as a 1-hour change, based on one-half the standard deviation.¹
Hypersomnia Carepath
2019 - 2021
A 2019-2021 analysis found only 27% of encounters in patients with central nervous system disorders of hypersomnolence were clinic visits; the remainder consisted of phone calls for refill requests, with no routine follow-up and no quality or safety assessments in place. A market research survey found scheduling was the biggest barrier to care, reported by 50% of patients. Since 2019, the Cleveland Clinic Sleep Disorders Center has realized a more than 300% increase in hypersomnia patients, while the number of providers increased only 50%, further complicating access and standardization. To address this challenge, a Hypersomnia Carepath was created in 2022 to detail visit type/cadence and frequency of pharmacotherapy safety monitoring with input from caregivers and patients. Growing patient volumes and care teams, changing prescribing regulations, and patient and caregiver frustration support one standard process for scheduling and monitoring hypersomnia patients. Preliminary feedback has been overwhelmingly positive, with more consistent care and safety monitoring, despite fewer phone calls and patient messages.
From 2022-2023 128 patients were enrolled.
