Co-morbid insomnia and OSA (COMISA) treatment trial using Oral Appliance Therapy
| ISRCTN | ISRCTN24516612 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24516612 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 240-402 |
| Sponsor | Panthera Dental |
| Funders | Panthera Dental, Investigator initiated and funded |
- Submission date
- 01/11/2024
- Registration date
- 07/11/2024
- Last edited
- 04/12/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
COMISA, which refers to co-existing insomnia and obstructive sleep apnea (OSA), is a highly debilitating disorder with a general population prevalence of 6%. Up to 50% of people with OSA have insomnia and 40% of people with insomnia have OSA. Positive airway pressure (PAP) use has been associated with a reduction in insomnia in some patients and is currently the standard of care for patients suffering from COMISA. Conversely, cognitive behavioural therapy for insomnia (CBTi) has been associated with a small decrease in OSA severity, probably because it consolidates sleep periods and reduces sleep-wake transitions to improve airway stability. Patients with COMISA experience significantly lower rates of PAP acceptance and use compared to those with OSA alone. Considering the high prevalence and mortality risk associated with unmanaged COMISA, alternative treatment approaches are required. Initial evidence suggests that oral appliance therapy (OAT) may be a favourable therapy in patients with COMISA, which will be more acceptable to patients, and reduce symptoms of both insomnia and OSA. To date, no previous study has investigated combinations of OAT and CBTi in patients with COMISA. Therefore, more research is required to investigate the real-world clinical utility of OAT paired with CBTi for the management of COMISA. This will be the focus of the POCC Pilot Study. The POCC Trial (pilot study) describes a clinical management protocol aimed at improving the care of patients with OSA, insomnia, and particularly those with overlapping conditions like COMISA. This observational study aims to investigate a novel management model for COMISA, combining CBTi, PAP therapy, and OAT.
Who can participate?
Consecutive patients aged between 18 and 80 years old enrolled in Ontario sleep clinics who are diagnosed with COMISA.
What does the study involve?
The protocol involves offering OAT after the prescription of PAP therapy for patients who refuse/cannot tolerate PAP. This sequential approach is not universally implemented for the care of OSA or COMISA, however, it is aligned with AASM and AADSM guidance.
Specifically, participants will be offered aPAP to manage their OSA. If adherent, they will be offered a cognitive behavioral therapy for insomnia (CBT-I) program for their insomnia. Once complete, they will take a final in-lab sleep study. If intolerant to, or through refusal of aPAP, they will be offered OAT. If adherent, they will be offered a CBTi program for their insomnia. Once complete, they will take a final in-lab sleep study.
Questionnaires will be completed 3 and 12 months after the final sleep study to establish the continued benefits of therapy. Once all questionnaires have been completed, the study obligations end, and study participants will continue to be monitored by their doctors as per usual and customary protocols.
What are the possible benefits and risks of participating?
Potential benefits include formalized guidance-based care and systematic scheduling, compilation of patient-centred and laboratory outcomes and cost savings for participants who complete all protocol steps.
Where is the study run from?
Sleep Disorders Dentistry Research and Learning Centre (Canada)
When is the study starting and how long is it expected to run for?
November 2024 to December 2026
Who is funding the study?
1. Panthera Dental, Canada (partial)
2. Investigator initiated and funded
Who is the main contact?
Dr Sherif Elsaraj, sherifelsaraj.cissso@ssss.gouv.qc.ca, Sherif.Elsaraj@McGill.Ca
Contact information
Public, Scientific, Principal investigator
1596 Walkley Road
Ottawa
K1V 6PN
Canada
 ORCID ID |
0000-0003-3134-3818 |
|---|---|
| Phone | +1 (613) 518-1888 |
| sherifelsaraj.cissso@ssss.gouv.qc.ca |
Public, Scientific, Principal investigator
Sleep Disorders Dentistry RLC., 5045 Orbitor Drive, Unit 10-300
Mississauga
L4W 4Y4
Canada
| ORCID ID |
0000-0002-2004-7776 |
|---|---|
| Phone | +1 9052127732 |
| john@drviviano.com |
Public, Scientific, Principal investigator
586 Eglinton Ave E, Suite 507
Toronto
M4P 1P2
Canada
| Phone | 9054677430 |
|---|---|
| j.macfarlane@medsleep.com |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational case-crossover study |
| Secondary study design | Case crossover study |
| Participant information sheet | 46329_PIS_DECLINED_CONSENT_V1.01.pdf |
| Scientific title | PAP-OAT-CBTi -COMISA Trial (POCC Trial) |
| Study acronym | POCC Trial |
| Study objectives | High adherence to oral appliance therapy (OAT) positions it as the preferred treatment alternative for patients suffering from co-morbid insomnia and obstructive sleep apnea (COMISA) compared to continuous positive airway pressure (PAP) therapy, which shows significantly lower adherence rates among this population. |
| Ethics approval(s) |
Not yet submitted |
| Health condition(s) or problem(s) studied | Co-existing insomnia and obstructive sleep apnea (OSA) (COMISA) |
| Intervention | 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-made, adjustable FDA-cleared appliance specifically made to assist breathing by keeping the tongue and jaw in a forward position during sleeping hours. The formalized sequence of offering OAT after a prescription of continuous positive airway pressure (PAP) therapy is not universally implemented for the care of obstructive sleep apnea (OSA) or more specifically co-morbid insomnia and obstructive sleep apnea (COMISA). Therefore, this pilot study will document outcomes associated with offering OAT for patients suffering from COMISA, if they prove intolerant to or refuse PAP. This trial is particularly important as the absence of data regarding outcomes with this protocol currently results in many of these patients remaining unmanaged. Participants will be offered aPAP to manage their OSA. If adherent, they will be offered a cognitive behavioral therapy for insomnia (CBT-I) program for their insomnia. Once complete, they will take a final in-lab sleep study. If intolerant to, or through refusal of aPAP, they will be offered OAT. If adherent, they will be offered a CBTi program for their insomnia. Once complete, they will take a final in-lab sleep study. Questionnaires will be completed 3 and 12 months after the final sleep study to establish the continued benefits of therapy. Once all questionnaires have been completed, the study obligations end, and study participants will continue to be monitored by their doctors as per usual and customary protocols. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Panthera D-SAD |
| Primary outcome measure(s) |
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: |
| Key secondary outcome measure(s) |
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 |
| Completion date | 31/12/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | All |
| Target sample size at registration | 300 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/12/2025 |
| Date of final enrolment | 31/12/2026 |
Locations
Countries of recruitment
- Canada
Study participating centre
Mississauga
L4W 4Y4
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Sherif Elsaraj, sherifelsaraj.cissso@ssss.gouv.qc.ca. All data collected will be entered into an Excel document that is confidential. The study participants will be assigned a number in a computer hard drive which will be destroyed by https://www.shredit.com/en-ca/secure-shredding-services/hard-drive-destruction. Their names corresponding to the numbers assigned will be stored in a locked desk with a key in the private clinic office of Sleep Disorders Dentistry Research and Learning Centre. Oral Appliance Bite Registration Data: • Vertical and Level of Protrusion o Baseline Mandibular range (Full Retrusive to Full Protrusive) o Baseline Most Advanced Protrusive Position of Comfort o Final Tested Position (Vertical and Level of Protrusion) Modified ESS Questionnaire: https://nasemso.org/wp-content/uploads/neuro-epworthsleepscale.pdf FOSQ10 Questionnaire: https://www.serenitymedicalservices.com/wp-content/uploads/2020/01/CEREVES_FOSQ_10_ENG.pdf SWIFT Questionnaire: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3501668/ RAND Questionnaire: https://www.rand.org/content/dam/rand/www/external/health/surveys_tools/mos/mos_sleep_survey.pdf ISI Questionnaire: https://www.sleepprimarycareresources.org.au/questionnaires/isi • At Baseline and all endpoints: All the above is captured with PSG and questionnaire. • At 3 months patient will take 7 nights of Home Sleep Testing with the Belun Ring. • At 3 and 12 months post reaching treatment endpoint: Questionnaires and questions provide ongoing assessment of maintenance of outcomes, and ongoing adherence. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1.01 | 08/11/2024 | No | Yes | |
| Participant information sheet | version 1.01 | 08/11/2024 | No | Yes | |
| Participant information sheet | 08/11/2024 | No | Yes | ||
| Participant information sheet | 08/11/2024 | No | Yes | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version 3.2 | 08/11/2024 | No | No | |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- 46329_Protocol_v3.2.pdf
- Protocol file
- 46329_PIS_DECLINED_CONSENT_V1.01.pdf
- Participant information sheet
- 46329_PIS_INFORMED_CONSENT_V1.01.pdf
- Participant information sheet
- 46329_PIS_OAT_Informed_Consent_2024.pdf
- Participant information sheet
- 46329_PIS_PAP_Informed_Consent_2024.pdf
- Participant information sheet
Editorial Notes
04/12/2025: The following changes were made to the study record:
1. The Completion date was changed from 30/06/2026 to 31/12/2026
2. The Date of first enrolment was changed from 01/04/2025 to 01/12/2025
3. The Date of final enrolment was changed from 10/12/2025 to 31/12/2026
17/02/2025: The following changes were made to the study record:
1. The overall study end date was changed from 10/12/2026 to 30/06/2026.
2. Exclusion criteria, intervention type, drug/device/biological/vaccine name(s), funder added.
27/01/2025: The recruitment start date was changed from 10/01/2025 to 01/04/2025.
11/11/2024: A study contact was updated.
08/11/2024: Internal review.
07/11/2024: Study's existence confirmed by Panthera Dental funding statement.
