Phototherapy for Non-responders to Oral Appliance Therapy for Obstructive Sleep Apnea

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alberta

About this trial

Obstructive sleep apnea (OSA) is a medical condition where a person has great difficulty with breathing, or stops breathing all together, while asleep. This is a medical condition for which one of the current standard treatments is the use of a custom made dental appliance to help hold the person's airway open while asleep so that the person does not suffocate while sleeping. However, while the majority of OSA patients are able to tolerate the use of oral appliance therapy (OAT) for OSA, some patients are incomplete responders to OAT. These patients, despite having improvement, may still have a disease index above the diagnostic threshold for OSA.

Phototherapy (laser therapy) has been used as a method to stiffen the soft palate and parts of the tongue to prevent their collapse. This is a type of cold laser therapy that does not cut/ablate tissue (similar to healing laser therapies). This has been shown to help with both snoring and can also help with OSA, as soft palate and tongue collapse are common areas for where OSA occurs inside the airway. A recent pilot study has shown that phototherapy on its own may be able to treat selected patients with mild, moderate, or severe OSA. To our knowledge, there are no contraindications to combining phototherapy and dental sleep appliance therapy.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

diagnosed with OSA

incomplete treatment with OAT/MAD

Disqualifiers

not diagnosed with OSA

using CPAP

Trial design

Design model

Parallel

Treatments tested in this trial

  • Phototherapy

    Device

    Non-surgical laser therapy (phototherapy)

Treatment groups

528 Participants
are divided into 3 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: NL C3Experimental treatment 1 intervention
Group C: QNExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

OSA disease index

Time frame
4 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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