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NCT04688125 · ClinicalTrials.gov registry record
Evaluation of An Optical Measurement Algorithm Combined With Patient and Provider Input to Reduce Mask Exchanges During Initial Positive Airway Pressure Therapy
A clinical trial of Sleep Apnea, Obstructive and Sleep Apnea Syndromes, sponsored by Mayo Clinic.
- Completed
- Registry status
- 67
- Enrollment target
- 1
- Study location
NCT04688125: Completed study of Sleep Apnea, Obstructive and Sleep Apnea Syndromes, sponsored by Mayo Clinic.
NCT04688125 is a study of Sleep Apnea, Obstructive and Sleep Apnea Syndromes that has completed, run by Mayo Clinic. The registered enrollment target is 67 participants, below the 261-participant average among 45 other Sleep Apnea, Obstructive trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04688125, a study of Sleep Apnea, Obstructive and Sleep Apnea Syndromes, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- 67 participants
- Enrollment target
- 1
- Study location
Study 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. 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 reli
Primary Outcome
Number of patient-initiated requests for mask changes during the first 90 days of PAP use
Conditions Studied
Study Locations (1)
Minnesota
- Mayo Clinic in Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2021-06-17 |
| Est. Completion | 2024-12-31 |
What the finished NCT04688125 record still lists
NCT04688125 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 261-participant average among 45 other Sleep Apnea, Obstructive trials with a reported enrollment target (74% lower).
The record links to 3 conditions, with Sleep Apnea, Obstructive appearing as the primary indexed condition, and to 0 interventions.
NCT04688125 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT04688125 about?
NCT04688125 is a clinical study titled "Evaluation of An Optical Measurement Algorithm Combined With Patient and Provider Input to Reduce Mask Exchanges During Initial Positive Airway Pressure Therapy". 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 a...
What is the current status of trial NCT04688125?
This trial is currently completed. The enrollment target is 67 participants. The study started on 2021-06-17. Estimated completion is 2024-12-31.
What conditions does trial NCT04688125 study?
This clinical trial studies the following conditions: Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Obesity Hypoventilation Syndrome (OHS).
Who is sponsoring clinical trial NCT04688125?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04688125 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04688125's enrollment target sits among peer trials
67 22nd of 45 higher than 24 of 45 other Sleep Apnea, Obstructive trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sleep Apnea, Obstructive trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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