Co-existing insomnia and obstructive sleep apnea (OSA) (COMISA) Nervous System Diseases
Conditions
Interventions
This is a patient management protocol with a formal care pathway. The goal is to offer the protocol to consecutive patients in Ontario sleep clinics. Oral appliance therapy (OAT) utilizes a custom-mad
Sponsors
Panthera Dental
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Adults 18-80 years of age 2. Non-pregnancy 3. Polysomnography (PSG) diagnosis available 4. Insomnia diagnosis 5. For OAT: More than 10 healthy teeth per arch with a healthy temporomandibular joint (TMJ) 6. For PAP: Must be a candidate for APAP set at 5-15 cmH2O pressure 7. Competent and able to comprehend English and sign consent form
Exclusion criteria
Exclusion criteria: Not meeting the participant inclusion criteria Added 17/02/2025: 1. Less than 18 years of age 2. Pregnancy 3. No polysomnography (PSG) diagnosis available 4. No insomnia diagnosis 5. Presents with TMJ-related pain 6. Not competent and able to comprehend English and unable to sign the consent form
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effectiveness of oral appliance therapy (OAT) in co-morbid insomnia and sleep apnea (COMISA) patients who are resistant or intolerant to PAP therapy is assessed using the following questionnaires at baseline, 3 and 12 months: 1. Daytime sleepiness measured using the Modified Epworth Sleepiness Scale (ESS) 2. The impact of sleepiness on daily activities measured using the Functional Outcomes of Sleep Questionnaire (FOSQ-10) 3. Patient-reported sleep quality and well-being measured using the Sleep Wellbeing Index for Treatment (SWIFT) 4. sleep duration, quality, and disturbances measured using the RAND Sleep Questionnaire 5. The severity of insomnia symptoms measured using the Insomnia Severity Index (ISI) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Impact of insomnia symptoms on adherence to PAP or OAT: Outcome: Influence of insomnia severity measured using the ISI on treatment adherence at 3 and 12 months 2. Alternative management for PAP non-responders: Outcome: Proportion of patients with PAP intolerance effectively managed with OAT, assessed using improvements in questionnaire scores 3. Effect of OAT on insomnia symptoms: Outcome: Change in ISI scores at 3 and 12 months 4. Dose-response relationship between OAT use and insomnia improvement: Outcome: Correlation between OAT usage frequency (hours per night) and ISI score reduction 5. Integration of OAT into current models of care: Outcome: Feasibility based on adherence rates and patient satisfaction (SWIFT scores) 6. Prevalence of COMISA in in-lab sleep study patients: Outcome: Proportion with COMISA identified in baseline assessments using the modified ESS and ISI | — |
Countries
Canada
Contacts
Public ContactSherif;John Elsaraj;Viviano
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Outcome results
None listed