Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
10 participants
INTERVENTIONAL
2026-01-31
2026-12-31
Brief Summary
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Detailed Description
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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:
1\. To determine if NPNT can effectively reduce the number of apnea-hypopnea index (AHI) events (sleep disorder breathing events) in healthy participants.
Secondary Objectives:
1. To determine the tolerability of the NPNT
2. To determine the duration of time required for acclimating to the device
3. To determine the NPNT parameters (optimal device fit) based on participant characteristics.
4. To collect feedback from participants regarding the device use, comfort, fit, function, usability, etc.
Safety and Efficacy Objectives:
1. To evaluate the safety and effectiveness of NPNT
2. To assess potential side effects of NPNT.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
DEVICE_FEASIBILITY
NONE
Study Groups
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Group 1
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
Negative Pressure Neck Therapy (NPNT)
Negative pressure neck therapy (NPNT) is a self-contained, non-invasive, soft, flexible, external neck collar
Group 2
One night of HSAT only, followed by 7 night washout, then one night of HSAT with NPNT intervention.
Negative Pressure Neck Therapy (NPNT)
Negative pressure neck therapy (NPNT) is a self-contained, non-invasive, soft, flexible, external neck collar
Interventions
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Negative Pressure Neck Therapy (NPNT)
Negative pressure neck therapy (NPNT) is a self-contained, non-invasive, soft, flexible, external neck collar
Eligibility Criteria
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Inclusion Criteria
* Able to speak, read, and write English
Exclusion Criteria
* 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
* 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
19 Years
ALL
Yes
Sponsors
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Vancouver Coastal Health Research Institute
OTHER
University of British Columbia
OTHER
Responsible Party
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John Fleetham
Professor
Principal Investigators
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John A Fleetham, MD
Role: PRINCIPAL_INVESTIGATOR
VCHA/UBC
Locations
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Centre for Lung Health
Vancouver, British Columbia, Canada
Leon Judah Blackmore Centre for Sleep Disorders
Vancouver, British Columbia, Canada
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Role: primary
Other Identifiers
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H25-02563
Identifier Type: -
Identifier Source: org_study_id