Penn Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Northwestern University, Feinberg School of Medicine, Chicago, IL, USA.
Sleep Med. 2023 Sep;109:65-74. doi: 10.1016/j.sleep.2023.05.023. Epub 2023 Jun 19.
The Transition Experience of persons with Narcolepsy taking Oxybate in the Real-world (TENOR) study was conducted to provide real-world insight into the experience of people with narcolepsy switching from sodium oxybate (SXB) to low-sodium oxybate (LXB; 92% less sodium than SXB).
TENOR is a patient-centric, prospective, observational, virtual-format study. Participants were adults with narcolepsy (type 1 or 2) who were transitioning from SXB to LXB treatment (±7 days from LXB initiation). Effectiveness and tolerability data were collected online from baseline (taking SXB) through 21 weeks (taking LXB) via daily and weekly diaries and questionnaires, including the Epworth Sleepiness Scale (ESS), the Functional Outcomes of Sleep Questionnaire, short version (FOSQ-10), and the British Columbia Cognitive Complaints Inventory (BC-CCI).
TENOR participants (N = 85) were 73% female with a mean (SD) age of 40.3 (13.0) years. Mean (SD) ESS scores decreased numerically throughout the transition from SXB to LXB (baseline: 9.9 [5.2]; week 21: 7.5 [4.7]), with 59.5% and 75.0% of participants having scores in the normal range (≤10) at baseline and week 21, respectively. Mean (SD) FOSQ-10 scores (baseline: 14.4 [3.4]; week 21: 15.2 [3.2]) and BC-CCI scores (baseline: 6.1 [4.4]; week 21: 5.0 [4.3]) also remained stable. The most common symptoms related to tolerability reported by participants at baseline were sleep inertia, hyperhidrosis, and dizziness (45.2%, 40.5%, and 27.4%, respectively), which decreased in prevalence by week 21 (33.8%, 13.2%, and 8.8%, respectively).
Findings from TENOR confirm maintenance of effectiveness and tolerability when transitioning from SXB to LXB treatment.
在现实世界中，接受羟丁酸钠（Oxybate）治疗的发作性睡病患者的过渡体验（TENOR）研究旨在提供发作性睡病患者的真实体验，这些患者正在从羟丁酸钠（SXB）过渡到低钠羟丁酸钠（LXB；SXB 的钠含量减少 92%）。
TENOR 是一项以患者为中心、前瞻性、观察性、虚拟格式的研究。参与者为正在从 SXB 过渡到 LXB 治疗的（±7 天内开始使用 LXB）1 型或 2 型发作性睡病成人。通过每日和每周日记和问卷，包括 Epworth 嗜睡量表（ESS）、睡眠功能结局问卷，简短版（FOSQ-10）和不列颠哥伦比亚认知投诉量表（BC-CCI），在线从基线（使用 SXB）到 21 周（使用 LXB）收集有效性和耐受性数据。
TENOR 参与者（N=85）中 73%为女性，平均（SD）年龄为 40.3（13.0）岁。从 SXB 过渡到 LXB 时，ESS 评分呈数值下降（基线：9.9 [5.2]；第 21 周：7.5 [4.7]），分别有 59.5%和 75.0%的参与者在基线和第 21 周的评分处于正常范围（≤10）。FOSQ-10 评分（基线：14.4 [3.4]；第 21 周：15.2 [3.2]）和 BC-CCI 评分（基线：6.1 [4.4]；第 21 周：5.0 [4.3]）也保持稳定。参与者在基线时报告的与耐受性相关的最常见症状为睡眠惯性、多汗和头晕，分别为 45.2%、40.5%和 27.4%，到第 21 周时，这些症状的发生率分别下降到 33.8%、13.2%和 8.8%。
TENOR 的研究结果证实，从 SXB 过渡到 LXB 治疗时，有效性和耐受性得以维持。
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