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.

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.

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.

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