Boyer Laurent, Philippe Carole, Covali-Noroc Ala, Dalloz Marie-Amélie, Rouvel-Tallec Anny, Maillard Dominique, Stoica Maria, d'Ortho Marie-Pia
APHP, Hôpital Henri Mondor, Département de Physiologie-Explorations Fonctionnelles, DHU A-TVB, Créteil, France.
Centre des pathologies du sommeil, Hôpital Universitaire de la Pitié Salpêtrière, AP-HP, Paris, France.
Clin Respir J. 2019 Jun;13(6):384-390. doi: 10.1111/crj.13022. Epub 2019 May 1.
Adherence to continuous positive airway pressure (CPAP) remains an issue, as adverse effects (AE) such as rhinitis, dry/congested nose, dry mouth or throat are commonly experienced. The aim of the study was to compare CPAP efficacy and tolerance in severe obstructive sleep apnea (OSA) patients with or without (w/o) heated humidification using the ThermoSmart system.
Multicenter RCT study in which CPAP-naive patients with severe OSA and meeting one or more of the following criteria: >65 years, using >1 drying medication, previous nasal symptoms or nasal surgery, were included. Patients were randomized to CPAP w/o heated humidification for 1 month and then crossed-over to the other treatment arm for another month. Naso-pharyngeal symptoms, Quality of life (FOSQ-10), sleepiness (ESS) and CPAP compliance and efficacy data were collected.
Forty patients were enrolled: age 62 ± 9 years, diagnostic AHI 46.7 ± 15.3/hour. About 70% were using >1 drying medication, mainly antihypertensives. Both treatment modalities were found to normalize AHI and decrease sleepiness with no differences between 2 modes, compliance (4.63 ± 0.39 vs 4.70 ± 0.36 h/night) or leaks (32.4 ± 2.0 versus 31.1 ± 1.7l/min). With heated humidification, there was a significant decrease in nasal symptoms such as dry/congested nose. At the study end, 26 patients preferred ThermoSmart ON, 3 did not have preference and 11 preferred ThermoSmart OFF.
ThermoSmart helps to decrease nose and throat discomfort because of CPAP therapy, these effects did not translate to better compliance but patients had a preference for ThermoSmart.
持续气道正压通气（CPAP）治疗的依从性仍是一个问题，因为患者常出现如鼻炎、鼻干/鼻塞、口干或咽干等不良反应（AE）。本研究旨在比较使用ThermoSmart系统进行加热湿化与未进行加热湿化的情况下，重度阻塞性睡眠呼吸暂停（OSA）患者的CPAP疗效及耐受性。
一项多中心随机对照试验（RCT）研究，纳入初次使用CPAP、患有重度OSA且符合以下一项或多项标准的患者：年龄>65岁、使用超过一种干燥药物、既往有鼻部症状或鼻部手术史。患者被随机分配至未进行加热湿化的CPAP治疗组，为期1个月，然后交叉至另一治疗组再进行1个月治疗。收集鼻咽喉症状、生活质量（FOSQ-10）、嗜睡程度（ESS）以及CPAP依从性和疗效数据。
共纳入40例患者，年龄62±9岁，诊断性呼吸暂停低通气指数（AHI）为46.7±15.3次/小时。约70%的患者使用超过一种干燥药物，主要为抗高血压药物。两种治疗方式均能使AHI恢复正常并减轻嗜睡程度，两种模式在依从性（4.63±0.39 vs 4.70±0.36小时/晚）或漏气情况（32.4±2.0与31.1±1.7升/分钟）方面无差异。使用加热湿化后，鼻干/鼻塞等鼻部症状显著减轻。研究结束时，26例患者更喜欢ThermoSmart开启状态，3例无偏好，11例更喜欢ThermoSmart关闭状态。
ThermoSmart有助于减轻CPAP治疗引起的鼻咽喉不适，这些效果虽未转化为更好的依从性，但患者更倾向于使用ThermoSmart。
