Evaluation of An Optical Measurement Algorithm Combined With Patient and Provider Input to Reduce Mask Exchanges During Initial Positive Airway Pressure Therapy

NCT04688125 | Completed

• 1 other identifier: 20-006272
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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 reliable method to reduce the errors in mask fitting so that the costs, inconvenience, and suffering are all reduced.

Conditions

Sleep Apnea, Obstructive; Obesity Hypoventilation Syndrome (OHS); Sleep Apnea Syndromes

Outcome Measures

Primary Outcomes (2)

• Mask exhange

  Number of patient-initiated requests for mask changes during the first 90 days of PAP use

  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.

  90 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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).

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

• 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.

  PMID: 32386696 BACKGROUND

• Avellan-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.

  PMID: 30621836 BACKGROUND

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Obesity Hypoventilation Syndrome; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Hypoventilation; Respiratory Insufficiency; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Timothy Morgenthaler, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 29, 2020
• Study Start: June 17, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available throughout the study and will continue to be analyzed on an ongoing basis after the study is completed.

Locations

US (1)