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

NCT07382206 | Recruiting

• 1 other identifier: 84402424.5.0000.5599
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periodic Leg Movements, Excessive, Sleep-Related

Keywords

Polysomnography; sleep; Device; Periodic Limb Movements of Sleep; Cardiopulmonary Exercise Test

Outcome Measures

Primary Outcomes (1)

• Sleep parameters measured by polysomnography

  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.

  7 days

Study Arms (2)

PLM Group

EXPERIMENTAL

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

Procedure: Cardiopulmonary Exercise Test (CPET) - Twice

Control Group

EXPERIMENTAL

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

Procedure: cardiopulmonary exercise test (CPET)

Interventions

cardiopulmonary exercise test (CPET) PROCEDURE

The participant will perform a single session of acute exercise 4 hours prior to polysomnography. On the same day, shortly before the polysomnography, study questionnaires will be administered, and the study devices (watch and ring) will be placed on the participant to record electrophysiological sleep parameters in conjunction with the polysomnography. The following morning, participants will be discharged and will continue to use the devices and complete study questionnaires at home for seven consecutive days. After the seven-day period, participants will return to undergo the second and final polysomnography. On this day, prior to the polysomnography, participants will complete study questionnaires, and advanced glycation end-products (AGEs) will be measured using the AGEs device and the smartwatch.

Control Group

Cardiopulmonary Exercise Test (CPET) - Twice PROCEDURE

The participant will undergo a single session of acute exercise (CPET) 4 hours prior to polysomnography (PSG). Before the PSG, study questionnaires will be administered, and the participant will wear study devices (smartwatch and smart ring) to collect sleep and physiological data during the night, in conjunction with the (PSG). The next day, participants will be discharged and begin a seven-day free-living period, during which they will continue using the devices at night. After this seven-day period, participants will return for a second PSG. On this day, prior to the PSG, participants will complete study questionnaires, and advanced glycation end-products (AGEs) will be measured using the AGE scanner device and the smartwatch. This description outlines the first block of the protocol. Following an interval of up to seven days to 3 weeks, the protocol will be repeated as described above, excluding the final PSG. This repetition constitutes the 2º block of the protocol.

PLM Group

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 22 years or older;
• 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. -

You may not qualify if:

• 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.
• 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.-

Sponsors & Collaborators

• Samsung Eletrônica da Amazônia Ltda: collaborator
• Associação Fundo de Incentivo à Pesquisa: lead

Study Sites (1)

CDEC Brasil

São Paulo, São Paulo, 04020060, Brazil

RECRUITING

MeSH Terms

Conditions

Nocturnal Myoclonus Syndrome

Interventions

Exercise Test; Clostridium perfringens epsilon-toxin

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Parasomnias

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Erika Cristine Treptow, PhD

  Instituto do Sono

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Magda Bignotto, PhD

CONTACT

5511971547331; magda.bignotto@cdecbrasil.com.br

Suelen Oliveira da Rosa, BPharm

CONTACT

551155790373; suelen.rosa@cdecbrasil.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Participants will be assigned to the PLM or control groups based on polysomnography results indicating the presence or absence of PLM events.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Effect of a single session of acute exercise on objective sleep patterns in adults with and without PLMS, as assessed by polysomnography. For this analysis, mobile and wearable devices will be employed to monitor physiological parameters that will serve as biomarkers of both exercise and sleep. In addition, study questionnaires will be administered, advanced glycation end-products (AGEs) will be evaluated, and participants will use the study devices (smartwatch and smart ring) at home for seven consecutive days.

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 2, 2026
• Study Start: December 24, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 30, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)