Fotobiomodulazione, Variabilità della Frequenza Cardiaca e Stress Acuto
L'Effetto della Fotobiomodulazione sulla Variabilità della Frequenza Cardiaca in Adulti Sani Sottoposti al Maastricht Acute Stress Test (MAST): Uno Studio Controllato con Sham, Within-subject
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Peter Wayne, PhD
- Numero di telefono: 617-732-6271
- Email: pwyane@bwh.harvard.edu
Backup dei contatti dello studio
- Nome: EunMee Yang, PhD
- Numero di telefono: 617-582-9291
- Email: eyang13@bwh.harvard.edu
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: 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. |
|
Comparatore fittizio: 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. |
|
Comparatore attivo: 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. |
|
Comparatore fittizio: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in HRV, as measured by RMSSD
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in electrodermal activity (EDA)
Lasso di tempo: 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)
Lasso di tempo: 50 minutes
|
BP will be assessed every 5 minutes during each visit's study procedures. |
50 minutes
|
|
Change in state anxiety
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Peter Wayne, Brigham and Women's Hospital
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 2026P000281
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .