How one session of intense exercise affects periodic leg movements during sleep

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

This project will test whether a single session of intense exercise changes periodic leg movements during sleep in adults with PLMS.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 22 Years and up
• Sex: All
• Sponsor: Associação Fundo de Incentivo à Pesquisa (Academic / other)
• Locations: 1 site (São Paulo, São Paulo)
• Trial ID: NCT07382206 on ClinicalTrials.gov

What this trial studies

This interventional study will enroll adults with Periodic Limb Movements of Sleep and compare an acute cardiopulmonary exercise test (CPET) intervention with a control condition. Participants will have a baseline or screening polysomnography to confirm a PLMS index ≥15/h and will be monitored overnight with standard PSG plus wearable sensors (smartwatch/smart ring) to record limb movements and sleep patterns. The protocol includes CPET performed per study schedule and repeat measurements to capture immediate effects on the PLMS index. Key exclusions are pregnancy, skin conditions or tattoos that interfere with optical sensors, implanted cardiac devices, and current PLMS medications.

Who should consider this trial

Good fit: Adults aged 22 or older who sleep at least five consecutive hours nightly and have a prior or screening polysomnography showing a PLMS index ≥15/h (with roughly half the sample targeted to have PLMS >50/h), who can attend overnight PSG visits and tolerate wearable sensors, are the ideal candidates.

Not a fit: People who are pregnant or lactating, have skin conditions or tattoos that prevent wearable sensor use, have implanted cardiac devices, are taking medications for sleep/PLMS, or cannot attend the PSG sessions would be ineligible and unlikely to benefit.

Why it matters

Potential benefit: If successful, this could point to a simple, non-drug way to reduce periodic limb movements and improve sleep for people with PLMS.

How similar studies have performed: Regular exercise is known to improve sleep, but the effects of a single intense exercise session on PLMS are largely untested, so this approach is relatively novel.

Eligibility 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.-

Where this trial is running

São Paulo, São Paulo

• CDEC Brasil — São Paulo, São Paulo, Brazil (Recruiting)

Study contacts

• Principal investigator: Erika Cristine Treptow, PhD — Instituto do Sono
• Study coordinator: Magda Bignotto, PhD

Conditions Periodic Leg Movements, Excessive, Sleep-Related; Polysomnography; sleep; Device; Periodic Limb Movements of Sleep; Cardiopulmonary Exercise Test