Pilot Study of Negative Pressure Neck Therapy (NPNT)

NCT07301567 | Not Yet Recruiting

• 1 other identifier: H25-02563
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Keywords

sleep apnea; Obstructive sleep apnea; sleep disordered breathing

Outcome Measures

Primary Outcomes (1)

• 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

  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)

  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.

  1 night

• Participant reported device tolerability will be assessed using the Device Evaluation Questionnaire Likert scale responses.

  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)

  1 night

• Participant Feedback on NPNT device comfort, usability and function based on the Device Evaluation Questionnaire using a Likert scale

  1 night

Other Outcomes (1)

• Adverse Events based on Device Evaluation Questionnaire responses to adverse device effects after NPNT intervention night and 7 night acclimatization period.

  8 nights

Study Arms (2)

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

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.

Device: Negative Pressure Neck Therapy (NPNT)

Interventions

Negative Pressure Neck Therapy (NPNT) DEVICE

Negative pressure neck therapy (NPNT) is a self-contained, non-invasive, soft, flexible, external neck collar

Group 1; Group 2

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index ≤42 kg/m2
• Able to speak, read, and write English

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of British Columbia: lead
• Vancouver Coastal Health Research Institute: collaborator

Study Sites (2)

Centre for Lung Health

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Leon Judah Blackmore Centre for Sleep Disorders

Vancouver, British Columbia, V6T 2B5, Canada

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Wake Disorders; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• John A Fleetham, MD

  VCHA/UBC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Manager

CONTACT

6048754111; Shelley.Abercromby@vch.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 24, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-11

Locations

CA (2)