Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 12:27 AM
NCT ID:
NCT07301567
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.
Detailed Description:
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.
Study:
NCT07301567
Study Brief:
Protocol Section:
NCT07301567