NCT07011966招募中不适用
Evaluation of Adaptive Servo Ventilation Therapy for Insomnia Treatment Among Patients With Primary Insomnia
ResMed1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2026年3月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Insomnia Severity Index (ISI) score
研究概览
简要总结
This will be a single center, prospective study designed to evaluate the effect of adaptive servo ventilation therapy on insomnia severity among patients with moderate to severe chronic insomnia.
详细描述
The primary objective of the study is to evaluate the effectiveness of adaptive servo ventilation therapy to reduce insomnia severity in primary insomnia patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years old
- •Complaint of insomnia when presenting at clinic
- •Diagnosis of moderate to severe insomnia through the Insomnia Severity Index (ISI) with a score ≥ 15
- •Meet diagnostic criteria of Insomnia Disorder (per American Academy of Sleep Medicine)
- •Naïve to treatment for sleep-disordered breathing (SDB), including CPAP, APAP, ASV; mandibular repositioning devices (MRDs), and any other nasal or oral therapy with a primary indication of treating SDB
- •Owns a smartphone and is able to install an application for HSAT data syncing.
- •Able to fully understand study information in English and sign informed consent
排除标准
- •Primary complaint of sleep-disordered breathing or issues with apneas during sleep or excessive daytime sleepiness
- •Pregnant or planning to be pregnant
- •Any prior diagnosis of severe respiratory disorder or severe sleep disorder such as restless leg syndrome (RLS), idiopathic hypersomnia, or narcolepsy
- •High risk for moderate to severe OSA based on STOP-BANG score.
- •BMI > 40 kg/m2
- •Anticipated changes to start or stop sedative or psychotropic medications during the course of the trial.
- •Medical history of congestive heart failure (CHF) or other potentially unstable cardiac disease as well as chronic lung diseases or other debilitating medical conditions that manifest as more prominent in the patient's health compared to their sleep complaints.
- •Daily use of opiate medications
- •Known contraindications to PAP therapy as listed in the indication for use (i.e. heart failure (NYHA 2-4) with reduced left ventricular ejection fraction (LVEF ≤45%) and moderate to severe predominant central sleep apnea).
- •Inability to pre-emptively comply with study procedures
- •Patients who wish to continue using sleeping pills/hypnotics during the study
- •Patients with conditions affecting the rotation of the condyle in the temporo-mandibular joint.
研究组 & 干预措施
ASV Therapy
Experimental
干预措施: ASV therapy (Device)
结局指标
主要结局
Insomnia Severity Index (ISI) score
时间窗: 4 weeks after therapy start
Change in insomnia severity from baseline to 4 weeks after treatment initiation, as measured by subjective questionnaire
次要结局
- Sleep Onset Latency(4 weeks after treatment initiation)
研究者
研究点 (1)
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