Negative Pressure Neck Therapy for Sleep Apnea
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing a new treatment called Negative Pressure Neck Therapy (NPNT) to determine its safety and effectiveness for obstructive sleep apnea (OSA), a condition where the airway collapses during sleep, causing breathing problems. Participants will undergo two home sleep tests and use the NPNT device on one of the nights. The study seeks healthy individuals without sleep disorders, such as sleep apnea, who can speak, read, and write English.
As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new solutions for sleep apnea.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators.
What prior data suggests that this device is safe for treating sleep apnea?
Research shows that Negative Pressure Neck Therapy (NPNT) is generally safe for short-term use. Studies on similar treatments, such as continuous negative external pressure (cNEP), have found them safe and effective for people with obstructive sleep apnea (OSA). Although specific safety data for NPNT is not yet available, these results suggest it might be well-tolerated. This trial is a pilot study with a small group, aiming to collect more safety data. Participants will use the NPNT device for just one night, reducing the risk of long-term side effects.12345
Why are researchers excited about this trial?
Researchers are excited about Negative Pressure Neck Therapy (NPNT) for sleep apnea because it offers a novel approach compared to traditional treatments like CPAP machines. NPNT works by applying negative pressure around the neck to help keep airways open during sleep, which could be less intrusive and more comfortable than wearing a mask. This method might encourage more people to stick with their treatment, as comfort often leads to better compliance. By offering a new way to manage sleep apnea, NPNT could provide a breakthrough for those struggling with current options.
What evidence suggests that Negative Pressure Neck Therapy is effective for sleep apnea?
Research has shown that Negative Pressure Neck Therapy (NPNT) might be a promising treatment for obstructive sleep apnea (OSA). One study demonstrated that NPNT significantly improved the Apnea-Hypopnea Index (AHI), a measure of sleep apnea severity, and increased oxygen levels during sleep for many individuals with moderate sleep apnea. This therapy helps keep airways open, reducing breathing interruptions. Another study found that a neck-based device improved sleep patterns and reduced the time spent sleeping on the back, which can worsen sleep apnea. In this trial, participants in Group 1 will experience one night of Home Sleep Apnea Testing (HSAT) with NPNT intervention, while Group 2 will have HSAT only before switching. These findings suggest NPNT may effectively support better breathing and sleep quality in OSA patients.12346
Who Is on the Research Team?
John A Fleetham, MD
Principal Investigator
VCHA/UBC
Are You a Good Fit for This Trial?
This trial is for individuals with a body mass index (BMI) of 42 or less who can speak, read, and write English. It's designed to help those suffering from sleep apnea disorders by testing a new therapy called NPNT.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Acclimatization
Participants undergo a 7-day acclimatization period to the NPNT device
Treatment
Participants use the NPNT device during one night of home sleep apnea testing
Washout
A 7-night washout period between intervention nights
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Negative Pressure Neck Therapy (NPNT)
Trial Overview
The study tests Negative Pressure Neck Therapy (NPNT) on up to 10 healthy participants to see if it's safe and effective for treating obstructive sleep apnea. Participants will use the NPNT device during one of two home sleep tests conducted about a week apart.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
One night of HSAT only, followed by 7 night washout, then one night of HSAT with NPNT intervention.
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of British Columbia
Lead Sponsor
Vancouver Coastal Health Research Institute
Collaborator
Citations
Pilot Study of Negative Pressure Neck Therapy (NPNT)
This pilot study will evaluate the Safety and Efficacy of Negative Pressure Neck Therapy (NPNT) in up to 10 healthy participants. Participants ...
2.
trial.medpath.com
trial.medpath.com/clinical-trial/fe631da03d1a9bdd/nct07301567-negative-pressure-neck-therapy-safety-effectivenessPilot Study of Negative Pressure Neck Therapy (NPNT)
This pilot study will evaluate the Safety and Efficacy of Negative Pressure Neck Therapy (NPNT) in up to 10 healthy participants. Participants ...
Negative Pressure Neck Therapy for Sleep Apnea
This pilot study will evaluate the Safety and Efficacy of Negative Pressure Neck Therapy (NPNT) in up to 10 healthy participants. Participants ...
Variable negative external pressure—an alternative to ...
In this pilot study, vNEP therapy markedly improved AHI and oxygenation in most patients with moderate OSA.
Assessment of a Neck-Based Treatment and Monitoring ...
The neck position therapy device is accurate and effective in restricting supine sleep, improving AHI, sleep architecture and continuity, and monitoring ...
Evaluation of Continuous Negative External Pressure (cNEP ...
In this pilot study, cNEP appears to be safe and effective during short-term use in subjects with OSA. Further studies are warranted.
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