NCT06960161

Brief Summary

Photobiomodulation (PBM) is a type of light therapy like lasers and LEDs. PBM was previously known by different terms like "low-level laser therapy" (LLLT) or "photobiostimulation." LLLT, despite its name, can also have effects beyond biomodulation, including thermal effects useful in medical imaging and therapy. PBM works by interacting with our biological systems, and its clinical benefits depend on factors like light wavelength, and energy output. PBM has various clinical applications, such as wound healing, pain management, and treatment in sports injuries. It's also used as an adjunct to surgery, reducing risks and improving outcomes in areas like wound healing and inflammation. In oral medicine, PBM is applied to conditions like oral aphthous ulcers and is well-recognized for its positive effects in treatment of oral inflammation for oncology patients. Recent studies indicate that PBM, when administered by trained professionals, can improve sleep quality and reduce snoring/SDB in adults. There's potential for its use in treating obstructive sleep apnea (OSA), showing effectiveness similar to dental sleep appliances but with fewer side effects. This effect seems to be from stabilization of the upper airway. Combining PBM with other therapies, like dental sleep appliances, has shown promise in enhancing effectiveness. However, whether the effect of PBM in stabilizing the upper airway to reduce snoring/SDB can be used in combination with continuous positive airway pressure (CPAP) to decrease CPAP pressures and improve patient compliance has not been explored.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
57mo left

Started Jan 2024

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Jan 2024Dec 2030

Study Start

First participant enrolled

January 5, 2024

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 28, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 7, 2025

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

May 7, 2025

Status Verified

April 1, 2025

Enrollment Period

7 years

First QC Date

April 28, 2025

Last Update Submit

April 28, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • CPAP pressure

    CPAP pressure

    12 months

Interventions

Phototherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • using CPAP
  • problems with CPAP tolerance/snoring

You may not qualify if:

  • not using CPAP

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Enjoy Dental

Edmonton, Alberta, T5X3N5, Canada

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Enoch Ng

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2025

First Posted

May 7, 2025

Study Start

January 5, 2024

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

May 7, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations