Obstructive ApneaNCT07301567
Pilot Study of Negative Pressure Neck Therapy (NPNT)
A study testing Negative Pressure Neck Therapy (NPNT) in people with Obstructive Apnea and Sleep Apnea Syndrome, Obstructive, run by University of British Columbia at 2 sites in Canada.
Trial summary
Obstructive sleep apnea (OSA) is a serious, chronic sleep-related breathing disease in which the upper airway repeatedly collapses during sleep, leading to intermittent oxygen deprivation. This pilot study will evaluate the Safety and Efficacy of Negative Pressure Neck Therapy (NPNT) in up to 10 healthy participants. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Apnea, Sleep Apnea Syndrome, Obstructive, Sleep Disorder (Disorder)
- What is being tested?
- Negative Pressure Neck Therapy (NPNT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesCanada
- Study dates
- Jan 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index ≤42 kg/m2
- Able to speak, read, and write English
Who cannot join
- Known sleep disorder such as Obstructive Sleep Apnea (OSA), narcolepsy, restless leg syndrome, idiopathic hypersomnolence or chronic insomnia
- No previous surgery, injury, or radiation to the neck
- Excessive hair or beard in the area of the neck, and/or unwillingness to shave that area for the duration of this study
- Inflammatory skin condition, such as acne or eczema in the neck area
- Known silicone allergy
- Night shift work because of irregular sleep-wake cycles
Show all 12Show fewer
- Excessive alcohol intake, defined as that leading to interference with work, home life, or the ability to optimally perform normal everyday duties and tasks
- Use of illicit drugs currently or within the past 5 years
- Serious pulmonary disease
- Use of home oxygen or oxygen saturation <94%
- Cancer that has been in remission for less than one year
- Previous surgery for peripheral arterial disease
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites
Centre for Lung Health
Vancouver, British Columbia, V5Z 1M9
6048754122
Leon Judah Blackmore Centre for Sleep Disorders
Vancouver, British Columbia, V6T 2B5
6048754122
About this study
Official title: A Proof-of-concept Pilot Study to Determine the Safety and Effectiveness of the Negative Pressure Neck Therapy (NPNT) in Healthy Participants.
Obstructive sleep apnea (OSA) is a serious, chronic sleep-related breathing disease in which the upper airway repeatedly collapses during sleep, leading to intermittent oxygen deprivation. This pilot study will evaluate the Safety and Efficacy of Negative Pressure Neck Therapy (NPNT) in up to 10 healthy participants. Participants will undergo 2 separate home sleep apnea tests (HSAT) approximately 1 week apart and will be randomly assigned to wear the NPNT device at either night 1 or night 2 of HSAT. Participation will include 5 on-site visits and 1 phone call over approximately 1 month.
Read the detailed description
Purpose: To determine the safety and efficacy of the Negative Pressure Neck Therapy (NPNT) in Healthy Participants.
Negative pressure neck therapy (NPNT) uses a self-contained, non-invasive, external device to apply a gentle, outward pulling effect around the neck's surface.
Hypothesis: Given the exploratory nature and small sample size no formal hypothesis testing will be conducted
Objectives:
Primary Objective:
- To determine if NPNT can effectively reduce the number of apnea-hypopnea index (AHI) events (sleep disorder breathing events) in healthy participants.
Secondary Objectives:
- To determine the tolerability of the NPNT
- To determine the duration of time required for acclimating to the device
- To determine the NPNT parameters (optimal device fit) based on participant characteristics.
- To collect feedback from participants regarding the device use, comfort, fit, function, usability, etc.
Safety and Efficacy Objectives:
- To evaluate the safety and effectiveness of NPNT
- To assess potential side effects of NPNT.
- Being tested
- Negative Pressure Neck Therapy (NPNT)
- Keywords
- sleep apnea, Obstructive sleep apnea, sleep disordered breathing
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Wake Disorders, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative Pressure Neck Therapy (NPNT)Device
Negative pressure neck therapy (NPNT) is a self-contained, non-invasive, soft, flexible, external neck collar
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | One night of Home sleep apnea testing (HSAT) with Negative Pressure Neck Therapy (NPNT) intervention, followed by 7 night washout, then one night of HSAT only Receives: Device: Negative Pressure Neck Therapy (NPNT) |
| Group 2 | Experimental | One night of HSAT only, followed by 7 night washout, then one night of HSAT with NPNT intervention. Receives: Device: Negative Pressure Neck Therapy (NPNT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the number of sleep-disordered breathing events between intervention and control nights as assessed by Home Sleep Apnea Test (HSAT).
Change between control night and intervention night on mean AHI (Apnea-Hypopnea Index) scores. A positive treatment effect will be attributed to the NPNT device if the difference between the mean AHI score on intervention night is less than the mean AHI score on control night. A score of less than 0 is positive.
Measurement Tool: HSAT (Home Sleep Apnea Test) Unit of Measure: AHI (Apnea-Hypopnea Index) scores
Measured: 1 night
Secondary outcomes (6)
Tolerability of NPNT device based on duration of time (hours) worn during NPNT intervention night as assessed by Participant Report and Home Sleep Apnea Test (HSAT)
Wear time (hours) of NPNT device will be assessed for each participant during the NPNT intervention night, after 7 day NPNT acclimatization period. Mean, median, range of tolerability of scores will be reported.
Measurement Tool: Participant Reported and HSAT (Home Sleep Apnea Test) Unit of Measure: hours
Measured: 1 night
Participant Characteristics will be assessed compared to NPNT device fit/shape based on participant response on the Device Evaluation Questionnaire using Likert scores.
Descriptive participant traits (age, BMI, craniofacial markers, etc.) will plotted against NPNT device fit/shape Likert scores from the Device Evaluation Questionnaire above and below a score of 3. For example, fit/shape Likert score rating by BMI category.
Measurement Tool: Device Evaluation Questionnaire and Participant demographics Unit of Measure: Likert Score
Measured: 1 night
Participant reported device tolerability will be assessed using the Device Evaluation Questionnaire Likert scale responses.
Proportion of participants rating NPNT device as "tolerable" (≥3 on Likert scale) during NPNT intervention night, after 7 day acclimatization period.
Measurement Tool: Device Evaluation Questionnaire Unit of Measure: Likert scale
Measured: 1 night
Participant Reported Feedback on shape and fit of NPNT device as assessed by the Device Evaluation Questionnaire using a Likert Scale (≥3 on Likert scale)
Proportion of participants rating device as "Moderate/good/excellent" (e.g., ≥3 on Likert scale). Mean, median, range of shape/fit scores, including a breakdown by demographic/ BMI group will be assessed after NPNT intervention night and 7 day acclimatation period.
Measurement Tool: Device Evaluation Questionnaire Unit of Measure: Likert scale
Measured: 1 night
Participant Feedback on NPNT device comfort, usability and function based on the Device Evaluation Questionnaire using a Likert scale
Proportion of participants rating device comfort, usability and function as ≥3 on Likert scale. Mean, median, range of device comfort, usability and function scores, including a breakdown by demographic/ BMI group will be assessed after NPNT intervention night and after 7 day acclimatation period.
Measurement Tool: Device Evaluation Questionnaire Unit of Measure: Likert scale
Measured: 1 night
Participant Feedback on NPNT device based on qualitative data (open comments) from the Device Evaluation Questionnaire after the NPNT device intervention night.
Qualitative data will be summarized using simple thematic coding based on participant open comment section of the Device Evaluation Questionnaire after the NPNT device intervention night, after 7 day acclimatization period.
Measurement Tool: Device Evaluation Questionnaire Unit of Measure: Qualitative data (open comments)
Measured: 1 night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study startJan 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive ApneaStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Vancouver Coastal Health Research Institute
- Responsible party
- Principal investigator, John Fleetham, University of British Columbia
- Investigators
- John A Fleetham, MD, Principal investigator, VCHA/UBC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07301567
- Sponsor's protocol ID
- H25-02563
- Status last verified
- Nov 2025
- First submitted
- 25 Nov 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This is a pilot study, so only IPD used in the results publication may be shared in the future.
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof-of-concept Pilot Study to Determine the Safety and Effectiveness of the Negative Pressure Neck Therapy (NPNT) in Healthy Participants.
- ClinicalTrials.gov ID
- NCT07301567
- Acronym / sponsor ID
- H25-02563
- Keywords
- sleep apnea, Obstructive sleep apnea, sleep disordered breathing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Vancouver Coastal Health Research Institute
- Study start
- Jan 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Dec 2025 (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.
Obstructive sleep apnea (OSA) is a serious, chronic sleep-related breathing disease in which the upper airway repeatedly collapses during sleep, leading to intermittent oxygen deprivation. This pilot study will evaluate the Safety and Efficacy of Negative Pressure Neck Therapy (NPNT) in up to 10 healthy participants. Participants will undergo 2 separate home sleep apnea tests (HSAT) approximately 1 week apart and will be randomly assigned to wear the NPNT device at either night 1 or night 2 of HSAT. Participation will include 5 on-site visits and 1 phone call over approximately 1 month.
Detailed description
Purpose: To determine the safety and efficacy of the Negative Pressure Neck Therapy (NPNT) in Healthy Participants.
Negative pressure neck therapy (NPNT) uses a self-contained, non-invasive, external device to apply a gentle, outward pulling effect around the neck's surface.
Hypothesis: Given the exploratory nature and small sample size no formal hypothesis testing will be conducted
Objectives:
Primary Objective:
- To determine if NPNT can effectively reduce the number of apnea-hypopnea index (AHI) events (sleep disorder breathing events) in healthy participants.
Secondary Objectives:
- To determine the tolerability of the NPNT
- To determine the duration of time required for acclimating to the device
- To determine the NPNT parameters (optimal device fit) based on participant characteristics.
- To collect feedback from participants regarding the device use, comfort, fit, function, usability, etc.
Safety and Efficacy Objectives:
- To evaluate the safety and effectiveness of NPNT
- To assess potential side effects of NPNT.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: Negative Pressure Neck Therapy (NPNT)One night of Home sleep apnea testing (HSAT) with Negative Pressure Neck Therapy (NPNT) intervention, followed by 7 night washout, then one night of HSAT only |
| Group 2 | Experimental | Device: Negative Pressure Neck Therapy (NPNT)One night of HSAT only, followed by 7 night washout, then one night of HSAT with NPNT intervention. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Body mass index ≤42 kg/m2
- Able to speak, read, and write English
Key exclusion criteria (12 listed)
- Known sleep disorder such as Obstructive Sleep Apnea (OSA), narcolepsy, restless leg syndrome, idiopathic hypersomnolence or chronic insomnia
- No previous surgery, injury, or radiation to the neck
- Excessive hair or beard in the area of the neck, and/or unwillingness to shave that area for the duration of this study
- Inflammatory skin condition, such as acne or eczema in the neck area
- Known silicone allergy
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 |
|---|---|---|
| Negative Pressure Neck Therapy (NPNT)Negative pressure neck therapy (NPNT) is a self-contained, non-invasive, soft, flexible, external neck collar | Device | Group 1, Group 2 |
Primary outcome
Comparison of the number of sleep-disordered breathing events between intervention and control nights as assessed by Home Sleep Apnea Test (HSAT).
Time frame: 1 night
Change between control night and intervention night on mean AHI (Apnea-Hypopnea Index) scores. A positive treatment effect will be attributed to the NPNT device if the difference between the mean AHI score on intervention night is less than the mean AHI score on control night. A score of less than 0 is positive. Measurement Tool: HSAT (Home Sleep Apnea Test) Unit of Measure: AHI (Apnea-Hypopnea Index) scores
6 secondary outcomes
Tolerability of NPNT device based on duration of time (hours) worn during NPNT intervention night as assessed by Participant Report and Home Sleep Apnea Test (HSAT)
Time frame: 1 night
Participant Characteristics will be assessed compared to NPNT device fit/shape based on participant response on the Device Evaluation Questionnaire using Likert scores.
Time frame: 1 night
Participant reported device tolerability will be assessed using the Device Evaluation Questionnaire Likert scale responses.
Time frame: 1 night
Participant Reported Feedback on shape and fit of NPNT device as assessed by the Device Evaluation Questionnaire using a Likert Scale (≥3 on Likert scale)
Time frame: 1 night
Participant Feedback on NPNT device comfort, usability and function based on the Device Evaluation Questionnaire using a Likert scale
Time frame: 1 night
Participant Feedback on NPNT device based on qualitative data (open comments) from the Device Evaluation Questionnaire after the NPNT device intervention night.
Time frame: 1 night
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: Undecided. This is a pilot study, so only IPD used in the results publication may be shared in the future.
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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.
John A Fleetham, MD principal investigator
VCHA/UBC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Negative Pressure Neck Therapy (NPNT) in people with Obstructive Apnea and Sleep Apnea Syndrome, Obstructive, run by University of British Columbia at 2 sites in Canada.
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 12 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: opening soon, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Research Manager (6048754111 ext. 62500, Shelley.Abercromby@vch.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the number of sleep-disordered breathing events between intervention and control nights as assessed by Home Sleep Apnea Test (HSAT). (time frame: 1 night). 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 24 Dec 2025.