Effect of Acute Exercise on Sleep Patterns in Patients With PLMS, Using a Wearable Device, Compared With a Control Group ( SONEX )

Associação Fundo de Incentivo à Pesquisa

Status: Enrolling

Conditions: Periodic Leg Movements, Excessive, Sleep-Related

Treatments: Procedure: Cardiopulmonary Exercise Test (CPET) - Twice; Procedure: cardiopulmonary exercise test (CPET)

Study type: Interventional

Funder types: Other

Identifiers

NCT07382206

84402424.5.0000.5599

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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. -

General Exclusion Criteria:

• 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.-

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

PLM Group

Experimental group

Description:

A single session of acute intense exercise will influence sleep-related biological parameters assessed by polysomnography, including the number of PLMS events.

Treatment:

Procedure: Cardiopulmonary Exercise Test (CPET) - Twice

Control Group

Experimental group

Description:

A single acute session of intense exercise will be reflected in sleep biological parameters measured by polysomnography, including the number of PLMS events.

Treatment:

Procedure: cardiopulmonary exercise test (CPET)