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

Sleep Disordered Breathing Clinical Trial

— 3DPiPPIn  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04179123
• Other study ID #: 18/0052
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2020
• Est. completion date: September 30, 2023

Study information

• Verified date: May 2023
• Source: University College, London
• Contact: Stephaie Mansell
• Phone: 02077940500
• Email: rf-tr.3dpippin[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Stage 1:

10 health participants. subjects will be asked to attend for a mask fitting using off the shelf standard mask stock. They will then be trialed on PAP therapy (breathing machine) for 10 minutes. Mask leak, skin reactions and comfort scores will be assessed.

Subjects will then attend for 3D printing of a mask. Following the production of the 3D mask, repeat measurements with the 3d mask on PAP therapy will be taken.

If all healthy subjects complete the trial without any serious adverse events, then the second phase of the study with patients will commence.

Stage 2:

Patients with an established diagnosis of sleep disordered breathing with known mask concerns will be recruited from the Royal Free London NHS Foundation Trust (RFL) Sleep and Ventilation Service. Subjects will be asked to attend for a mask fitting using their existing mask standard stock and will be trialed on PAP therapy (breathing machine) for 10 minutes. Mask leak, skin reactions and comfort scores will be assessed. Any side effects will be documented via photographs. The number and cost of previous masks used since starting PAP therapy (breathing machine) will be also be recorded.

Patients will then attend for 3D printing of a mask and repeat measurements with the 3D mask on 10 minutes of their usual PAP therapy will be taken. If there are no serious adverse events/reactions during the PAP trial with the 3D printed mask patients will go on to have a one-night trial on PAP therapy as per their normal PAP (breathing machine) regime. If there are no adverse events or reactions during the one-night trial then patients will proceed to a further four nights of trial with the 3D printed mask. A comparison of scores will be made with standard and 3D printed masks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Healthy:

Inclusion Criteria:

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

Exclusion Criteria:

• Staff with known sleep disordered breathing. Staff with suggestion of sleep disordered breathing on the STOP Bang and Epworth Sleepiness Score screening tools

Patients

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Sleep Apnea Syndromes
• Sleep Disordered Breathing

Intervention

Device:
• Customised PAP interfaces
Customised PAP interfaces

Locations

Country	Name	City	State
United Kingdom	Royal Free London NHS foundation Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
University College, London	Royal Free Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Comfort	Measured with self developed mask comfort questionnaire. Combination of questions answered on a Visual Analogue Scale (1-5) scale, open questions and binary questions. No overall score produced	5 days
Secondary	Side effects	Measured with self developed mask comfort questionnaire. Combination of questions answered on a VAS scale, open questions and binary questions. No overall score produced.; Objective assessment of skin to assess for skin reactions, graded with the EUPAP 0-4.	5 days
Secondary	Mask leak	Measured via SD data card download. Leak a l/min as an average over 5 nights	5 days