Efficiency of Intermittent Hypoxia Intervention in Primary Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- The polysomnography between IH group and control group
研究概览
简要总结
The purpose of this study was to understand the effectiveness of intermittent hypoxia in the treatment of primary insomnia.
详细描述
Insomnia is a sleep disorder characterized by frequent and persistent difficulties in falling asleep or maintaining sleep, and resulting in inadequate sleep satisfaction. Insomnia is a common sleep problem with a prevalence of 10% to 15% in adults and a chronic course that may increase with age, with nearly half of those with severe insomnia lasting more than 10 years.Insomnia can increase the risk of some diseases, such as anxiety, depression, hypertension, diabetes and cardiovascular diseases. Insomnia is closely related to the body's chronic inflammatory response, and studies have shown that insomnia induces a chronic inflammatory response in the body, which impairs the structure and integrity of sleep, leading to an increased inflammatory response in the body, which in turn impairs the health.
Intermittent hypoxia (IH) refers to periodic hypoxic-normoxic training performed with brief exposure to hypoxia. Previous studies have shown that short-term intermittent hypoxia can produce neuroprotective effects, inhibit inflammatory response, and promote neurological recovery, providing a new approach for the treatment of primary insomnia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects are diagnosed with primary insomnia between 18 and 60 years old，gender is not limited.
- •Patients who are not taking sedative-hypnotic drugs or have stopped taking drugs for more than 2 weeks.
- •Residing in the plains all year round and not having been above 1500 meters above sea level in the past 30 days.
- •Quiet state SaO2 ≥ 90%, cerebral oxygen saturation 58-82%, heart rate 60-100 beats/min, blood pressure 90-140/60-90 mmHg, respiratory rate 16-20 times/min.
- •No functional drinks, caffeine-containing beverages, or sleep-disturbing medications during the study period.
排除标准
- •Stroke onset in the past 3 months, other severe neurological diseases, such as epilepsy, intracranial infectious diseases or demyelination.
- •Uncontrolled hypertension (systolic blood pressure ≥200mmHg) with antihypertensive drugs before enrollment, other cardiovascular diseases.
- •History of pulmonary, hepatic, dermatologic, or hematologic diseases.
- •History of substance abuse.
- •Pregnancy, Severe sleep apnea and neurological disorders.
研究组 & 干预措施
IH group
Participants will receive 10 times intermittent hypoxia (oxygen concentration: 13%) intervention.
干预措施: Intermittent Hypoxia (Other)
Control group
Participants will receive 10 times sham-hypoxia (oxygen concentration: 21%) intervention in 5 days.
干预措施: Sham Intermittent Hypoxia (Other)
结局指标
主要结局
The polysomnography between IH group and control group
时间窗: Baseline and Day 7
Before and after the experiment, polysomnography was performed on both the experimental and control groups to record sleep latency, total sleep duration, as well as the duration and proportion of each sleep stage.
次要结局
- Concentration of serum parameters between IH group and control group(Baseline and Day 7)
- The score of Insomnia Severity Index（ISI）(Baseline and Day 7)
- The score of the Flinders Fatigue Scale (FFS)(Baseline and Day 7)
- The scale of Self-Rating Anxiety Scale (SAS)(Baseline and Day 7)
- The score of Self-Rating Depression Scale (SDS)(Baseline and Day 7)
- Peripheral Oxygen Saturation (SpO₂)(Day 1-7)
- Heart Rate(Day 1-7)
- Respiratory Rate(Day 1-7)
- Blood Pressure(Day 1-7)
研究者
Ji Xunming,MD,PhD
Principal Investigator
Capital Medical University