Sleep Disordered Breathing3DPiPPInNCT04179123
3D Printing of Positive Airway Pressure (PAP) Therapy Masks: a Single Site Pilot and Feasibility Study
A study testing Customised PAP interfaces in people with Sleep Disordered Breathing, run by University College, London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Disordered Breathing
- What is being tested?
- Customised PAP interfaces
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Mar 2020to 30 Oct 2024
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Members of staff working at Royal Free London NHS Foundation Trust
- 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
Who cannot join
- 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 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Free London NHS foundation Trust
London, NW3 2QG
About this study
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.
Read the detailed 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.
- Conditions
- Sleep Disordered Breathing
- Being tested
- Customised PAP interfaces
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Customised PAP interfacesDevice
Customised PAP interfaces
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Experimental | Conventional and customised PAP interfaces Receives: Device: Customised PAP interfaces |
| Patients | Experimental | Conventional and customised PAP interfaces Receives: Device: Customised PAP interfaces |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 days
Secondary outcomes (3)
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
Measured: 5 days
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.
Measured: 5 days
Mask leak
Measured via SD data card download. Leak a l/min as an average over 5 nights
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start15 Mar 2020
- Primary completion30 Oct 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Disordered BreathingStudies of the same condition, open and under way.
- More trials run by University College, LondonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Two phase feasibility trial: Phase 1: 10 healthy subjects Phase 2: 10 patients already on PAP therapy
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Free Hospital NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04179123
- Sponsor's protocol ID
- 18/0052
- Acronym
- 3DPiPPIn
- Status last verified
- Nov 2024
- First submitted
- 15 Nov 2019
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Printing of Positive Airway Pressure (PAP) Therapy Masks: a Single Site Pilot and Feasibility Study
- ClinicalTrials.gov ID
- NCT04179123
- Acronym / sponsor ID
- 3DPiPPIn / 18/0052
- Conditions
- Sleep Disordered Breathing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Royal Free Hospital NHS Foundation Trust
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 27 Nov 2019 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two phase feasibility trial: Phase 1: 10 healthy subjects Phase 2: 10 patients already on PAP therapy
| Arm | Type | Receives |
|---|---|---|
| Healthy | Experimental | Device: Customised PAP interfacesConventional and customised PAP interfaces |
| Patients | Experimental | Device: Customised PAP interfacesConventional and customised PAP interfaces |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Members of staff working at Royal Free London NHS Foundation Trust
- 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
Key exclusion criteria (3 listed)
- 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 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Customised PAP interfacesCustomised PAP interfaces | Device | Healthy, Patients |
Primary outcome
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
Time frame: 5 days
Acceptability of 3D printed customised PAP masks by patients and healthcare professionals
3 secondary outcomes
Comfort
Time frame: 5 days
Side effects
Time frame: 5 days
Mask leak
Time frame: 5 days
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 22 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Sleep Disordered Breathing
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
RecruitingObservational study
Prediction of Tongue Base Obstruction During Sleep
Obstructive Sleep Disordered Breathing
RecruitingObservational study
Characterization of the Tongue in Children With Obstructive Sleep-disordered Breathing
Obstructive Sleep Disordered Breathing
Not yet recruitingObservational study
Registry of Central Sleep Apnea Patients Undergoing remedē System Implant
Central Sleep Apnea (Diagnosis), Central Sleep Apnea Syndrome
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Customised PAP interfaces in people with Sleep Disordered Breathing, run by University College, London at 1 site in United Kingdom.
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 2 inclusion and 3 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 22 Nov 2024. 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 Kingdom. 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?
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 (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Nov 2024.