Actively Recruiting
Effect of Acute Exercise on Sleep Patterns in Patients With PLMS, Using a Wearable Device, Compared With a Control Group ( SONEX )
Led by Associação Fundo de Incentivo à Pesquisa · Updated on 2026-02-02
150
Participants Needed
1
Research Sites
70 weeks
Total Duration
On this page
Sponsors
A
Associação Fundo de Incentivo à Pesquisa
Lead Sponsor
S
Samsung Eletrônica da Amazônia Ltda
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Effect of Acute Exercise on Sleep Patterns in Patients With PLMS, Using a Wearable Device, Compared With a Control Group ( SONEX )
Who Can Participate
Eligibility Criteria
You may qualify if you...
General
- 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
You will not qualify if you...
- 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.-
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
CDEC Brasil
São Paulo, São Paulo, Brazil, 04020060
Actively Recruiting
Research Team
M
Magda Bignotto, PhD
CONTACT
S
Suelen Oliveira da Rosa, BPharm
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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