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

January 26, 2026 updated by: Associação Fundo de Incentivo à Pesquisa

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • São Paulo
      • São Paulo, São Paulo, Brazil, 04020060
        • Recruiting
        • CDEC Brasil
        • Contact:
        • Contact:
        • Principal Investigator:
          • Erika Cristine Treptow, PhD
        • Sub-Investigator:
          • Marlon Manhães Faes, MD
        • Sub-Investigator:
          • Pedro Henrique Ribeiro, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PLM Group
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

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.
Experimental: 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.
Procedure: cardiopulmonary exercise test (CPET)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep parameters measured by polysomnography
Time Frame: 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.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Associação Fundo de Incentivo à Pesquisa

Collaborators

Samsung Eletrônica da Amazônia Ltda

Investigators

  • Principal Investigator: Erika Cristine Treptow, PhD, Instituto do Sono

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 24, 2024

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

January 26, 2026

First Submitted That Met QC Criteria

January 26, 2026

First Posted (Actual)

February 2, 2026

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 26, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 84402424.5.0000.5599

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The parties have agreed that the data will be shared with the study collaborator exclusively in anonymized form.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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