Fotobiomodulacja, zmienność rytmu serca i ostry stres
Wpływ fotobiomodulacji na zmienność rytmu serca u zdrowych dorosłych poddanych testowi stresu ostrego Maastricht (MAST): Badanie kontrolowane pozorowane (sham) w układzie wewnątrzpodmiotowym
Photobiomodulation (PBM) is a form of light therapy that uses red or near-infrared light to influence biological processes. In prior studies, PBM has been shown to improve various physiological functions, including tissue repair, inflammation, and cognitive performance. However, little is known about its impact on autonomic nervous system regulation. Thus, the goal of this study is to evaluate the effects of PBM on vagal activity, as measured by heart rate variability (HRV), in healthy adults undergoing experimental stress.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
Photobiomodulation (PBM) is a non-invasive therapeutic technique that uses low-level light, typically in the red or near-infrared spectrum, to stimulate biological tissues. This approach has been increasingly studied for its beneficial effects on wound healing, mood, and sleep quality. Recent research has also highlighted PBM's potential in enhancing brain function, neuroplasticity, and cognitive performance. For example, prior studies have demonstrated that transcranial PBM (i.e., PBM delivered to the head) can help modulate neuronal activity, improve cerebral blood flow, and promote neuroprotective effects for traumatic brain injury and stroke. Given these findings, PBM may also have potential for influencing autonomic function and stress physiology. However, to date, little is known about the effects of PBM on the autonomic nervous system, particularly its influence on vagal activity and heart rate variability (HRV).
This study aims to fill this gap by investigating the effects of transcutaneous cervical plus intranasal PBM on HRV in healthy individuals subjected to experimental stress. Specifically, the Maastricht Acute Stress Test (MAST) will be used, which is a validated stress protocol that has been shown to strongly and reliably induce acute autonomic stress responses. A within-subject design will be employed with four repeated visits per participant to examine the effects of both PBM and sham intervention applied before and after stress induction on vagal activity, as measured by HRV. As the first study to examine PBM's impact on HRV, this research will provide valuable insights into the potential of PBM as a novel, non-invasive approach to modulating autonomic regulation, particularly in the context of stress.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Peter Wayne, PhD
- Numer telefonu: 617-732-6271
- E-mail: pwyane@bwh.harvard.edu
Kopia zapasowa kontaktu do badania
- Nazwa: EunMee Yang, PhD
- Numer telefonu: 617-582-9291
- E-mail: eyang13@bwh.harvard.edu
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Healthy adults, aged 18-64 years
- Ability to read and understand English
- Willing to comply with the study procedures and attend all scheduled sessions
Exclusion Criteria:
- Taking medications that could significantly influence autonomic function
- Presence or history of any serious cardiovascular, inflammatory, and pain conditions as well as neurological disorders or other conditions that affect the central nervous system
- Pregnant
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Randomizowane
- Model interwencyjny: Zadanie krzyżowe
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Aktywny komparator: Real PBM before stress induction
After a 5-minute baseline measurement, participants will receive 20 minutes of real PBM. They will then complete the 15-minute MAST protocol (stress induction) and be monitored for additional 10 minutes to assess recovery from stress. |
In this study, PBM will be administered using a transcutaneous cervical plus intranasal PBM device (Vielight Vagus, Ontario, Canada). The transcutaneous component of the device is designed to be placed bilaterally over the lateral aspect of the neck and delivers an irradiance of 810nm at 50mW/cm2, while the intranasal component is designed to be inserted into the nasal cavity and provides an irradiance of 810nm at 25mW/cm2. The pulse frequency will be set to 100 Hz and 50% duty cycle. |
|
Pozorny komparator: Sham PBM before stress induction
After a 5-minute baseline measurement, participants will receive 20 minutes of sham PBM. They will then complete the 15-minute MAST protocol (stress induction) and be monitored for additional 10 minutes to assess recovery from stress. |
For sham intervention, the same PBM device will be placed on the participants in the same manner, but without emitting light to ensure blinding of the intervention. |
|
Aktywny komparator: Real PBM after stress induction
After a 5-minute baseline measurement, participants will undergo the 15-minute MAST protocol (stress induction), followed by 20 minutes of real PBM and 10 minutes of post-intervention period. |
In this study, PBM will be administered using a transcutaneous cervical plus intranasal PBM device (Vielight Vagus, Ontario, Canada). The transcutaneous component of the device is designed to be placed bilaterally over the lateral aspect of the neck and delivers an irradiance of 810nm at 50mW/cm2, while the intranasal component is designed to be inserted into the nasal cavity and provides an irradiance of 810nm at 25mW/cm2. The pulse frequency will be set to 100 Hz and 50% duty cycle. |
|
Pozorny komparator: Sham PBM after stress induction
After a 5-minute baseline measurement, participants will undergo the 15-minute MAST protocol (stress induction), followed by 20 minutes of sham PBM and 10 minutes of post-intervention period. |
For sham intervention, the same PBM device will be placed on the participants in the same manner, but without emitting light to ensure blinding of the intervention. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in HRV, as measured by RMSSD
Ramy czasowe: 50 minutes
|
Root mean square of successive differences (RMSSD) is a commonly used time-domain measure of HRV. It is commonly used to assess autonomic regulation, with higher RMSSD indicating greater parasympathetic activity and vagal tone. In this study, RMSSD will be calculated for every 5-minute segments of HRV data from baseline to post-phase. The area under the curve (AUC) will be computed to assess changes in RMSSD values with respect to baseline. This approach will allow for a comprehensive evaluation of changes in parasympathetic activity, in both magnitude and variability over time under different experimental conditions. Paired t-tests will then be used to compare AUCs between PBM and sham interventions, separately for before and after stress induction. |
50 minutes
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in electrodermal activity (EDA)
Ramy czasowe: 50 minutes
|
Similar to ECG/HRV, EDA data will be measured continuously from baseline to post-phase for 50 minutes, to provide a more comprehensive assessment of the autonomic responses. |
50 minutes
|
|
Change in blood pressure (BP)
Ramy czasowe: 50 minutes
|
BP will be assessed every 5 minutes during each visit's study procedures. |
50 minutes
|
|
Change in state anxiety
Ramy czasowe: 50 minutes
|
Participants will be asked to complete the state anxiety subscale of the State-Trait Anxiety Inventory (STAI) two times for each visit, initially before baseline and then during the post-phase period. |
50 minutes
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Peter Wayne, Brigham and Women's Hospital
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- 2026P000281
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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