Effect of Acute Exercise on Sleep Patterns in Patients With PLMS Using a Wearable Device Compared With a Control Group
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Sleep parameters measured by polysomnography
研究概览
简要总结
The effects of chronic exercise on health promotion, improvement of quality of life, and reduction of the risk of developing chronic diseases such as obesity, diabetes mellitus, cardiovascular diseases, depression, and cancer are well established. In addition, the positive influence of exercise on sleep patterns and sleep quality is widely recognized. However, few studies have addressed the effects of a single session of physical exercise on the circadian cycle and sleep disorders.
Regarding Periodic Limb Movement Disorder (PLMD), which is characterized by periodic episodes of repetitive and highly stereotyped limb movements, the scientific literature indicates that the effects of a single session of intense exercise remain insufficiently explored. Therefore, the present study aims to investigate, through a controlled interventional study, the effects of acute exercise on the Periodic Limb Movements of Sleep (PLMS) index.
To this end, the study will recruit healthy participants as well as individuals with PLMS to perform acute exercise sessions, followed by a polysomnographic examination and a longitudinal observation period. Throughout the study, participants will use wearable and mobile devices to monitor their physiological patterns. In addition, questionnaires related to sleep, physical exercise, cognitive decline, and depression will be administered to better characterize the study population.
Thus, this study aims to generate evidence regarding the influence of acute exercise on sleep patterns in participants with PLMS, as well as to obtain data to support the development of algorithms related to sleep quality, including PLMS detection, which may be embedded in wearable or mobile devices in the future.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Participants will be assigned to the PLM or control groups based on polysomnography results indicating the presence or absence of PLM events.
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •General Inclusion Criteria:
- •Aged 22 years or older;
- •Self-reported habitual sleep of at least 5 consecutive hours per night. Specific Inclusion Criteria for the PLMS Group
- •Having a prior polysomnography (PSG) showing a PLMS index ≥ 15/h;
- •Screening PSG for participants without a PSG in the last 6 months showing a PLMS index ≥ 15/h.
- •Note: Efforts will be made to ensure that approximately 50% of the sample consists of participants with a PLMS index > 50/h. -
排除标准
- •Pregnant or lactating individuals;
- •Presence of dermatological conditions or skin diseases such as vitiligo, lupus, atopic dermatitis, or tattoos on the wrist or fingers that could interfere with optical sensor readings from the smartwatch or smart ring;
- •Inability to attend the study PSG sessions;
- •Use of medications indicated for the treatment of sleep disorders;
- •Current or prior treatment for PLMS management;
- •Presence of implanted cardiac devices, such as pacemakers, cardioverter defibrillators, or cardiac resynchronization devices;
- •Prior diagnosis of chronic neurological, orthopedic, cardiac, pulmonary, or other clinical conditions that limit the ability to perform physical activity.
- •Specific Exclusion Criteria for the Control Group:
- •Presence of sleep disorders identified on the screening PSG, such as: moderate to severe sleep apnea (apnea-hypopnea index [AHI] ≥ 15), insomnia with an Insomnia Severity Index (ISI) score above 14, or PLMS index > 15.-
研究组 & 干预措施
PLM Group
A single session of acute intense exercise will influence sleep-related biological parameters assessed by polysomnography, including the number of PLMS events.
干预措施: Cardiopulmonary Exercise Test (CPET) - Twice (Procedure)
Control Group
A single acute session of intense exercise will be reflected in sleep biological parameters measured by polysomnography, including the number of PLMS events.
干预措施: cardiopulmonary exercise test (CPET) (Procedure)
结局指标
主要结局
Sleep parameters measured by polysomnography
时间窗: 7 days
A single acute session of intense exercise will be reflected in sleep-related biological parameters measured by polysomnography, including the number of PLMS events. Furthermore, the exercise effect will also be compared between two different groups: individuals with PLMS and those without PLMS.
次要结局
未报告次要终点