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NCT Number: NCT07301567

Pilot Study of Negative Pressure Neck Therapy (NPNT)

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.

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Key information

Conditions

Obstructive Apnea Apnea Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Sleep Apnea Syndrome, Obstructive Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorder (Disorder) Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Lung Health, Vancouver, British Columbia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Negative Pressure Neck Therapy (NPNT)

Device

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

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).

    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

Secondary outcomes

  1. 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

    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

  2. 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

    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

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

    Time frame: 1 night

    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

  4. 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

    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

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

    Time frame: 1 night

    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

  6. 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

    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)

Other outcomes

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

    Time frame: 8 nights

    Device specific adverse events (skin irritation, redness or rash, discomfort or pain, swelling, other) will be assessed using a scale of 1 to 5 (not at all, mild, moderate, severe, very severe) after the NPNT intervention night and 7 night acclimatization period.

    Measurement Tool: Device Evaluation Questionnaire Unit of Measure: Scale of 1-5 (1-not at all, 2-mild, 3-moderate, 4-severe, 5-very severe)

Study contacts

Contact information is provided by the study sponsor or research team.

Research Manager

CONTACT

[email protected]

6048754111 ext. 62500

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Vancouver Coastal Health Research Institute

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 24, 2025
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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