NCT07301567

Pilot Study of Negative Pressure Neck Therapy (NPNT)

A Proof-of-concept Pilot Study to Determine the Safety and Effectiveness of the Negative Pressure Neck Therapy (NPNT) in Healthy Participants.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

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. 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: 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

• Obstructive Apnea
• Sleep Apnea Syndrome, Obstructive
• Sleep Disorder (Disorder)

Interventions

Type	Name	Description
DEVICE	Negative Pressure Neck Therapy (NPNT)	Negative pressure neck therapy (NPNT) is a self-contained, non-invasive, soft, flexible, external neck collar

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-12-24
• Last updated: 2025-12-24

Locations

2 sites across 1 country: Canada