PillowsPlus nasal cannula for sleep
| ISRCTN | ISRCTN13124681 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13124681 |
| Secondary identifying numbers | Health Canada Investigational Testing Authorization #381594 |
- Submission date
- 24/09/2025
- Registration date
- 10/10/2025
- Last edited
- 02/10/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
This study is testing a new nasal oxygen interface, called the PillowsPlus Nasal Cannula (PPNC). The goal is to see if it improves oxygen delivery during sleep for patients who use long-term oxygen therapy. Standard nasal cannulas can fail to deliver enough oxygen when people breathe through their mouths or during sleep. The new device is designed to fix this problem by making portable oxygen concentrators more reliable.
Who can participate?
Adults (18 years and older) prescribed up to 6 liters per minute of oxygen can join. People with moderate or severe sleep apnea, those who need nighttime CPAP/BiPAP, or those fully dependent on mechanical ventilation cannot take part. Patients with significant facial injuries that prevent use of nasal cannulas are also excluded.
What does the study involve?
Participation lasts about 4 days. Each participant completes three overnight sleep studies at home wearing a pulse oximeter and using different combinations of oxygen equipment:
Night 1: Standard cannula with a stationary oxygen concentrator.
Nights 2 and 3: Either the new PPNC or a standard cannula with a portable concentrator (order randomized).
Oxygen levels and heart rate are recorded, and participants fill out comfort questionnaires.
What are the possible benefits and risks of participating?
Potential benefits include helping to improve portable oxygen therapy devices for future patients. Risks are minimal but may include discomfort from the cannula or lower oxygen levels. A physician will review safety data, and unsafe results will lead to stopping further testing for that participant.
Where is the study run from?
Northern Alberta Institute of Technology (NAIT) (Canada)
When is the study starting and how long is it expected to run for?
August 2024 to August 2025
Who is funding the study?
Pulmvita Inc. with support from Alberta Innovates (AICE–Validate Grant and Health Innovation Platform Partnership Grant) (Canada)
Who is the main contact?
Dr Daniel Vis, daniel.vis@ucalgary.ca
Contact information
Public, Scientific, Principal investigator
4448 Front St SE
Calgary
T3M 1M4
Canada
 ORCID ID |
0009-0002-9343-626X |
|---|---|
| Phone | +1 (0)403 956 2800 |
| daniel.vis@ucalgary.ca |
Study information
| Study design | Multicenter interventional single-blinded randomized cross over trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Home |
| Study type | Safety |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Determining the effects of a PillowsPlus Nasal Cannula on oxygenation during ambulation and sleep |
| Study objectives | The study aims to determine the effects of the PillowsPlus Nasal Cannula (PPNC) on oxygenation during sleep. |
| Ethics approval(s) |
1. Approved 26/08/2024, University of Alberta Research Ethics Office (11312 – 89 Avenue NW, Edmonton, T6G 2N2, Canada; +1 (0)780 492 9724; reoffice@ualberta.ca), ref: UofA REB ID: Pro00148005 2. Approved 26/08/2024, Northern Alberta Institute of Technology Research Ethics Board (11762 - 106 Street, Edmonton, T5G 2R1, Canada; +1 (0)780 471 6248; reb@nait.ca), ref: NAIT REB ID: 2024-08 |
| Health condition(s) or problem(s) studied | Nocturnal oxygenation in patients on long-term oxygen therapy |
| Intervention | We performed a three-night, two-sequence cross over study, adults on long-term oxygen therapy slept one night with a standard nasal cannula on a stationary continuous-flow concentrator (baseline), one night with PillowsPlus nasal cannula (PPNC) on continuous flow, and one night with PPNC on a pulsed-flow concentrator. The method of randomization was randomization software set to produce an even distribution across conditions. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | PillowsPlus nasal cannula |
| Primary outcome measure | Nocturnal average SpO2 by pulse oximetry, measured at baseline with a standard cannula + stationary concentrator compared to a PillowsPlus nasal cannula + a portable concentrator and a PillowsPlus nasal cannula + stationary concentrator on sequential nights. Designed and powered for non-inferiority. |
| Secondary outcome measures | 1. Nocturnal average heart rate by pulse oximetry, measured at baseline with a standard cannula +stationary concentrator compared to a PillowsPlus nasal cannula +stationary concentrator and a PillowsPlus nasal cannula + stationary concentrator on sequential nights. 2. Frequency of oxygen desaturation events of 3% or greater by pulse oximetry, measured by blinded, manual scoring of oximetry data by a respirologist. Baseline recorded with standard cannula +stationary concentrator, compared to a PillowsPlus nasal cannula +stationary concentrator and a PillowsPlus nasal cannula + stationary concentrator on sequential nights. 3. Patient comfort data as measured with patient surveys at baseline with standard cannula +stationary concentrator, compared to a PillowsPlus nasal cannula +stationary concentrator and a PillowsPlus nasal cannula + stationary concentrator on sequential nights. |
| Overall study start date | 26/08/2024 |
| Completion date | 22/08/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target number of participants | 27 |
| Total final enrolment | 27 |
| Key inclusion criteria | Patients aged over 18 years on chronic domiciliary oxygen therapy |
| Key exclusion criteria | 1. Requiring >6 L of O2 per minute at baseline 2. Previously established need for any nocturnal positive airway pressure therapy for conditions such as CPAP for obstructive sleep apnea (OSA), ASV for central sleep apnea, or BiPAP for obesity hypoventilation syndrome 3. Patients fully dependent on mechanical ventilation and/or those with facial injuries that preclude the use of a standard cannula or the PPNC will be excluded 4. Patients with an Apnea-Hypopnea Index (AHI) >15 will be excluded from further testing |
| Date of first enrolment | 05/06/2025 |
| Date of final enrolment | 22/08/2025 |
Locations
Countries of recruitment
- Canada
Study participating centres
Edmonton
T5G 2R1
Canada
Edmonton
T6G 2N2
Canada
Sponsor information
Government
1500, 10104 – 103 Avenue NW
Edmonton
T5J 0H8
Canada
| Phone | +1 (0)780 423 5727 |
|---|---|
| info@albertainnovates.ca | |
| Website | http://albertainnovates.ca/ |
"ROR" |
https://ror.org/00ynafe15 |
Funders
Funder type
Industry
No information available
No information available
Results and Publications
| Intention to publish date | 31/10/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analyzed during the current study will be available upon request from Efrem Violato (efrem@nait.ca) or Daniel Vis (daniel.vis@ucalgary.ca). The study will collect oxygen saturation and heart rate data from pulse oximetry, comfort questionnaire responses, and basic demographics. All data are coded by study ID, with identifiers stored separately and securely by the principal investigator. Data will be stored securely for at least 5 years and then destroyed. Only de-identified, coded datasets are shared between the investigators at NAIT and Pulmvita Inc. Analyses will compare oxygen delivery and patient comfort, with results published in aggregate only. Data sharing is limited to anonymised files exchanged between research partners; there is no open-access repository. Written informed consent is obtained, and participants may withdraw their data before publication. Ethical restrictions prevent identifiable data from leaving the study team. Any withdrawals, adverse events, or protocol deviations will be reported in the final outputs. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other files | Comfort Questionnaire | 02/10/2025 | No | No | |
| Other files | Consent Form | 02/10/2025 | No | No |
Additional files
- 48062 Comfort Questionnaire.pdf
- Comfort Questionnaire
- 48062 Consent Form.pdf
- Consent Form
Editorial Notes
25/09/2025: Study's existence confirmed by Alberta Innovates.
