Periodic Leg Movements, Excessive, Sleep-RelatedSONEXNCT07382206
Effect of Acute Exercise on Sleep Patterns in Patients With PLMS, Using a Wearable Device, Compared With a Control Group ( SONEX )
A study testing cardiopulmonary exercise test (CPET) and Cardiopulmonary Exercise Test (CPET) - Twice in people with Periodic Leg Movements, Excessive, Sleep-Related, run by Associação Fundo de Incentivo à Pesquisa at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodic Leg Movements, Excessive, Sleep-Related
- What is being tested?
- cardiopulmonary exercise test (CPET) and Cardiopulmonary Exercise Test (CPET) - Twice
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteBrazil
- Study dates
- 24 Dec 2024to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
CDEC Brasil
São Paulo, São Paulo, 04020060
Magda Bignotto, PhD, 5511971547331, magda.bignotto@cdecbrasil.com.br
Suelen Oliveira da Rosa, BPharm, 551155790373, sueli.rosa@cdecbrasil.com.br
About this study
Official title: 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.
Read more
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.
- Being tested
- cardiopulmonary exercise test (CPET), Cardiopulmonary Exercise Test (CPET) - Twice
- Keywords
- Polysomnography, sleep, Device, Periodic Limb Movements of Sleep, Cardiopulmonary Exercise Test
- Medical subject headings
- Nocturnal Myoclonus Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiopulmonary exercise test (CPET)Procedure or surgery
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.
Cardiopulmonary Exercise Test (CPET) - TwiceProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: cardiopulmonary exercise test (CPET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start24 Dec 2024
- Primary completion1 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodic Leg Movements, Excessive, Sleep-RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Associação Fundo de Incentivo à Pesquisa
- Sponsor type
- University, hospital or other
- Collaborators
- Samsung Eletrônica da Amazônia LTDA
- Responsible party
- Sponsor
- Investigators
- Erika Cristine Treptow, PhD, Principal investigator, Instituto do Sono
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07382206
- Sponsor's protocol ID
- 84402424.5.0000.5599
- Acronym
- SONEX
- Status last verified
- Jan 2026
- First submitted
- 26 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The parties have agreed that the data will be shared with the study collaborator exclusively in anonymized form.
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acute Exercise on Sleep Patterns in Patients With PLMS Using a Wearable Device Compared With a Control Group
- ClinicalTrials.gov ID
- NCT07382206
- Acronym / sponsor ID
- SONEX / 84402424.5.0000.5599
- Keywords
- Polysomnography, sleep, Device, Periodic Limb Movements of Sleep, Cardiopulmonary Exercise Test
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Associação Fundo de Incentivo à PesquisaUniversity, hospital or other
- Collaborators
- Samsung Eletrônica da Amazônia LTDA
- Study start
- 24 Dec 2024 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| PLM Group | Experimental | Procedure: Cardiopulmonary Exercise Test (CPET) - TwiceA single session of acute intense exercise will influence sleep-related biological parameters assessed by polysomnography, including the number of PLMS events. |
| Control Group | Experimental | Procedure: cardiopulmonary exercise test (CPET)A single acute session of intense exercise will be reflected in sleep biological parameters measured by polysomnography, including the number of PLMS events. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Control Group |
| Cardiopulmonary Exercise Test (CPET) - TwiceThe 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. | Procedure or surgery | PLM Group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: No. The parties have agreed that the data will be shared with the study collaborator exclusively in anonymized form.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Erika Cristine Treptow, PhD principal investigator
Instituto do Sono
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cardiopulmonary exercise test (CPET) and Cardiopulmonary Exercise Test (CPET) - Twice in people with Periodic Leg Movements, Excessive, Sleep-Related, run by Associação Fundo de Incentivo à Pesquisa at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Magda Bignotto, PhD (5511971547331, magda.bignotto@cdecbrasil.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep parameters measured by polysomnography (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.