Periodic Leg Movements, Excessive, Sleep-Related
Conditions
Keywords
Polysomnography, sleep, Device, Periodic Limb Movements of Sleep, Cardiopulmonary Exercise Test
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.
Interventions
PROCEDUREcardiopulmonary 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.
PROCEDURECardiopulmonary 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.
Sponsors
Associação Fundo de Incentivo à Pesquisa
Samsung Eletrônica da Amazônia Ltda
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
Participants will be assigned to the PLM or control groups based on polysomnography results indicating the presence or absence of PLM events.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep parameters measured by polysomnography | 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. |
Countries
Brazil
Contacts
CONTACTMagda Bignotto, PhD
CONTACTSuelen Oliveira da Rosa, BPharm
PRINCIPAL_INVESTIGATORErika Cristine Treptow, PhD
Instituto do Sono
Outcome results
None listed