Pilot Study of Negative Pressure Neck Therapy (NPNT)

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

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)

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

Participant Characteristics will be assessed compared to NPNT device fit/shape based on participant response on the Device Evaluation Questionnaire using Likert scores.

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

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

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

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)

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

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

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)