3D Printing of Positive Airway Pressure (PAP) Therapy Masks: a Single Site Pilot and Feasibility Study

NCT04179123 | Completed

• 1 other identifier: 18/0052
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single site pilot and feasibility study. We propose that 3D printing could be used to create customised masks for patients requiring Positive Airway Pressure (PAP) therapy. We hypothesise that the use of this technology may result in; improved compliance with therapy, increased comfort, reduced side effects, increased quality of life and reduced healthcare costs.

Conditions

Sleep Disordered Breathing

Outcome Measures

Primary Outcomes (1)

• To pilot the feasibility of using 3D printing technology to develop customised masks for patients receiving PAP therapy. This will be assessed through the secondary outcome measures and the Medical Research Council Complex Intervention Framework

  Acceptability of 3D printed customised PAP masks by patients and healthcare professionals

  5 days

Secondary Outcomes (3)

• Comfort

  5 days

• Side effects

  5 days

• Mask leak

  5 days

Study Arms (2)

Healthy

EXPERIMENTAL

Conventional and customised PAP interfaces

Device: Customised PAP interfaces

Patients

EXPERIMENTAL

Conventional and customised PAP interfaces

Device: Customised PAP interfaces

Interventions

Customised PAP interfaces DEVICE

Customised PAP interfaces

Healthy; Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Members of staff working at Royal Free London NHS Foundation Trust

You may not qualify if:

• Staff with known sleep disordered breathing. Staff with suggestion of sleep disordered breathing on the STOP Bang and Epworth Sleepiness Score screening tools
• Patients
• Patients will be recruited from the existing sleep and ventilation database at RFL. Patients with an established diagnosis of sleep disordered breathing with known interface concerns will be recruited. Patients who have been identified as having problematic interface concerns resulting in mask leak, poor mask fit, pressure ulcers and reduced effectiveness of PAP therapy
• Patients who are clinically unstable as assessed by a clinical member of the research team. Patients with evidence of active infection on clinical assessment. Patients who have dependent on their therapy for more than 16 hours in a 24 hour period. Patients with active pressure ulcers.

Sponsors & Collaborators

• University College, London: lead
• Royal Free Hospital NHS Foundation Trust: collaborator

Study Sites (1)

Royal Free London NHS foundation Trust

London, NW3 2QG, United Kingdom

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two phase feasibility trial: Phase 1: 10 healthy subjects Phase 2: 10 patients already on PAP therapy

Study Record Dates

• First Submitted: November 15, 2019
• First Posted: November 27, 2019
• Study Start: March 15, 2020
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)