Pilot Study of Negative Pressure Neck Therapy (NPNT)

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Negative Pressure Neck Therapy (NPNT)
  Negative pressure neck therapy (NPNT) is a self-contained, non-invasive, soft, flexible, external neck collar

Первичные конечные точки

• Comparison of the number of sleep-disordered breathing events between intervention and control nights as assessed by Home Sleep Apnea Test (HSAT). [Срок оценки: 1 night]

Вторичные конечные точки (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) [Срок оценки: 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. [Срок оценки: 1 night]
• Participant reported device tolerability will be assessed using the Device Evaluation Questionnaire Likert scale responses. [Срок оценки: 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) [Срок оценки: 1 night]
• Participant Feedback on NPNT device comfort, usability and function based on the Device Evaluation Questionnaire using a Likert scale [Срок оценки: 1 night]
• Participant Feedback on NPNT device based on qualitative data (open comments) from the Device Evaluation Questionnaire after the NPNT device intervention night. [Срок оценки: 1 night]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Оценка устройства

Центры проведения

Канада · 2 центра

• Centre for Lung Health — Vancouver
• Leon Judah Blackmore Centre for Sleep Disorders — Vancouver

Идентификаторы

NCT: NCT07301567 · H25-02563

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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