Sleep Apnea, ObstructiveNCT04688125
Evaluation of An Optical Measurement Algorithm Combined With Patient and Provider Input to Reduce Mask Exchanges During Initial Positive Airway Pressure Therapy
An observational study of Sleep Apnea, Obstructive and Obesity Hypoventilation Syndrome (OHS), run by Mayo Clinic at 1 site in United States.
Trial summary
Continuous positive airway pressure and non-invasive ventilation are common treatment modalities for obstructive sleep apnea, central sleep apnea, and chronic alveolar hypoventilation from a variety of causes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive, Obesity Hypoventilation Syndrome (OHS), Sleep Apnea Syndromes
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2021to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female age ≥18 years old who initiating PAP therapy for obstructive sleep apnea (OSA), obesity hypoventilation syndrome (OHS), or central sleep apnea syndrome (CSA).
Who may be able to join
- Age ≥18 years old
- Sleep testing shows an apnea-hypopnea index or respiratory event index ≥5
- Patient is PAP naïve or no PAP use within the last 10 years
- Patient's diagnosis is obstructive sleep apnea, obesity hypoventilation syndrome, or central sleep apnea syndrome
- Prescribed therapy is CPAP, A-PAP, or BPAP in a spontaneous modality
- Patient is able to provide consent
- Patient is English speaking (limited to English for device)
Who cannot join
- Prescribed therapy is BPAP ST or ASV
- Patient is not able to provide consent
- Patient is not able to speak or read English
- Nasal or facial trauma or surgery that leaves atypical facial features
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Continuous positive airway pressure and non-invasive ventilation are common treatment modalities for obstructive sleep apnea, central sleep apnea, and chronic alveolar hypoventilation from a variety of causes. Use of positive airway pressure (PAP) requires use of an interface, commonly referred to as a "mask." There are a range of mask options available, differing in configuration and sizing, including masks that fit into the nostrils (nasal pillows, NP), cover the nose (nasal masks, NM), cover both the nose and the mouth (oronasal masks, ONM), and rarely those that fit into the mouth (oral masks, OM) or over the entire face. The variety of masks, sizes, and materials result from the wide variety of facial configurations and patient preferences along with requirements to provide a good seal for varying pressure requirements. Failure to find a good match for a given patient may result in significant side effects, such as eye irritation owing to leak into the eyes, skin pressure sores, noise generation, and inadequate therapy when air leaks are extreme. Pressure sores, mask dislodgement, claustrophobic complaints, air leaks, and sore eyes occur in 20-50% of patients with OSA receiving PAP, and these effects negatively correlate with PAP compliance. Furthermore, several trials point to differences in compliance related to which types of masks are utilized. In a randomized cross-over trial, compliance was 1 hour more per night in patients using NM compared to those using ONM.1 In another, NPs were associated with fewer adverse effects and better subjective sleep quality than NMs.2 Therefore, failure to find an acceptable mask results in lower or non-compliance, and therefore treatment failure.
Currently, finding a right mask is performed either using crude templates, or via an iterative process, variably guided by experts in mask fitting. There are no standard certifications or algorithms to guide mask fitting. Given the above, it would be very desirable to find a reliable method to reduce the errors in mask fitting so that the costs, inconvenience, and suffering are all reduced.
Read the detailed description
Patients will be recruited from Mayo Clinic sleep medicine practices who have completed testing and are initiating PAP therapy for obstructive sleep apnea (OSA), obesity hypoventilation syndrome (OHS), or central sleep apnea syndrome (CSA). Testing will be performed for clinical reasons on patients referred for evaluation for sleep disordered breathing. Testing is at the clinician's discretion and can be either polysomnography or home sleep apnea tests. Patients meeting inclusion and not meeting exclusion criteria will be offered the opportunity to participate in this study.
Participating patients will be randomized into one of two groups: the Active group or the Usual Care. A member of the study team register each patient to use the MaskFit AR™ mobile application to take facial measurements and generate mask recommendations. The patient will then be provided with a list recommendations and will be invited to use this list to select their mask from their durable medical equipment company. This is the differentiating part of the study, with the recommendation for a mask being decided by the patient's group assignment. The recommendation for masks may or may not be different from the one written on initial prescription. After the initial visit at the study center, all participants will also be contacted for a follow-up call and will also be asked to complete brief online surveys, one after 40 days and one after 90 days following the first visit.
- Medical subject headings
- Sleep Apnea, Obstructive, Obesity Hypoventilation Syndrome, Sleep Apnea Syndromes
What is being measured
The primary outcome is the main question the study is designed to answer.
Mask exhange
Number of patient-initiated requests for mask changes during the first 90 days of PAP use
Measured: 90 days
PAP Satisfaction
Measured using the PAP satisfaction questionnaire. CPAP Questionnaire is a 12 item questionnaire, with items 1-6 a Likert like scale asking about various types of discomfort, and questions 7-12 using a 100 mm VAS to answer questions related to PAP and sleep satisfaction.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start17 Jun 2021
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timothy Morgenthaler, Mayo Clinic
- Investigators
- Timothy Morgenthaler, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04688125
- Sponsor's protocol ID
- 20-006272
- Status last verified
- Feb 2025
- First submitted
- 8 Dec 2020
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this study, after deidentification, may be shared with other researchers.
Publications
Dibra MN, Berry RB, Wagner MH. Treatment of Obstructive Sleep Apnea: Choosing the Best Interface. Sleep Med Clin. 2020 Jun;15(2):219-225. doi: 10.1016/j.jsmc.2020.02.008.
PubMed 32386696Avellan-Hietanen H, Brander P, Bachour A. Symptoms During CPAP Therapy Are the Major Reason for Contacting the Sleep Unit Between Two Routine Contacts. J Clin Sleep Med. 2019 Jan 15;15(1):47-53. doi: 10.5664/jcsm.7568.
PubMed 30621836
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of An Optical Measurement Algorithm Combined With Patient and Provider Input to Reduce Mask Exchanges During Initial Positive Airway Pressure Therapy
- ClinicalTrials.gov ID
- NCT04688125
- Acronym / sponsor ID
- 20-006272
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 17 Jun 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 29 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Continuous positive airway pressure and non-invasive ventilation are common treatment modalities for obstructive sleep apnea, central sleep apnea, and chronic alveolar hypoventilation from a variety of causes. Use of positive airway pressure (PAP) requires use of an interface, commonly referred to as a "mask." There are a range of mask options available, differing in configuration and sizing, including masks that fit into the nostrils (nasal pillows, NP), cover the nose (nasal masks, NM), cover both the nose and the mouth (oronasal masks, ONM), and rarely those that fit into the mouth (oral masks, OM) or over the entire face. The variety of masks, sizes, and materials result from the wide variety of facial configurations and patient preferences along with requirements to provide a good seal for varying pressure requirements. Failure to find a good match for a given patient may result in significant side effects, such as eye irritation owing to leak into the eyes, skin pressure sores, noise generation, and inadequate therapy when air leaks are extreme. Pressure sores, mask dislodgement, claustrophobic complaints, air leaks, and sore eyes occur in 20-50% of patients with OSA receiving PAP, and these effects negatively correlate with PAP compliance. Furthermore, several trials point to differences in compliance related to which types of masks are utilized. In a randomized cross-over trial, compliance was 1 hour more per night in patients using NM compared to those using ONM.1 In another, NPs were associated with fewer adverse effects and better subjective sleep quality than NMs.2 Therefore, failure to find an acceptable mask results in lower or non-compliance, and therefore treatment failure.
Currently, finding a right mask is performed either using crude templates, or via an iterative process, variably guided by experts in mask fitting. There are no standard certifications or algorithms to guide mask fitting. Given the above, it would be very desirable to find a reliable method to reduce the errors in mask fitting so that the costs, inconvenience, and suffering are all reduced.
Detailed description
Patients will be recruited from Mayo Clinic sleep medicine practices who have completed testing and are initiating PAP therapy for obstructive sleep apnea (OSA), obesity hypoventilation syndrome (OHS), or central sleep apnea syndrome (CSA). Testing will be performed for clinical reasons on patients referred for evaluation for sleep disordered breathing. Testing is at the clinician's discretion and can be either polysomnography or home sleep apnea tests. Patients meeting inclusion and not meeting exclusion criteria will be offered the opportunity to participate in this study.
Participating patients will be randomized into one of two groups: the Active group or the Usual Care. A member of the study team register each patient to use the MaskFit AR™ mobile application to take facial measurements and generate mask recommendations. The patient will then be provided with a list recommendations and will be invited to use this list to select their mask from their durable medical equipment company. This is the differentiating part of the study, with the recommendation for a mask being decided by the patient's group assignment. The recommendation for masks may or may not be different from the one written on initial prescription. After the initial visit at the study center, all participants will also be contacted for a follow-up call and will also be asked to complete brief online surveys, one after 40 days and one after 90 days following the first visit.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female age ≥18 years old who initiating PAP therapy for obstructive sleep apnea (OSA), obesity hypoventilation syndrome (OHS), or central sleep apnea syndrome (CSA).
Key inclusion criteria (7 listed)
- Age ≥18 years old
- Sleep testing shows an apnea-hypopnea index or respiratory event index ≥5
- Patient is PAP naïve or no PAP use within the last 10 years
- Patient's diagnosis is obstructive sleep apnea, obesity hypoventilation syndrome, or central sleep apnea syndrome
- Prescribed therapy is CPAP, A-PAP, or BPAP in a spontaneous modality
Key exclusion criteria (4 listed)
- Prescribed therapy is BPAP ST or ASV
- Patient is not able to provide consent
- Patient is not able to speak or read English
- Nasal or facial trauma or surgery that leaves atypical facial features
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mask exhange
Time frame: 90 days
Number of patient-initiated requests for mask changes during the first 90 days of PAP use
PAP Satisfaction
Time frame: 90 days
Measured using the PAP satisfaction questionnaire. CPAP Questionnaire is a 12 item questionnaire, with items 1-6 a Likert like scale asking about various types of discomfort, and questions 7-12 using a 100 mm VAS to answer questions related to PAP and sleep satisfaction.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Background: PubMed 32386696Dibra MN, Berry RB, Wagner MH. Treatment of Obstructive Sleep Apnea: Choosing the Best Interface. Sleep Med Clin. 2020 Jun;15(2):219-225. doi: 10.1016/j.jsmc.2020.02.008.
- Background: PubMed 30621836Avellan-Hietanen H, Brander P, Bachour A. Symptoms During CPAP Therapy Are the Major Reason for Contacting the Sleep Unit Between Two Routine Contacts. J Clin Sleep Med. 2019 Jan 15;15(1):47-53. doi: 10.5664/jcsm.7568.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this study, after deidentification, may be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Morgenthaler, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea, Obstructive and Obesity Hypoventilation Syndrome (OHS), run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mask exhange (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04688125, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.