Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Vancouver Coastal Health Research Institute | OTHER |
Not provided
Not provided
Not provided
Not provided
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:
Safety and Efficacy Objectives:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | One night of Home sleep apnea testing (HSAT) with Negative Pressure Neck Therapy (NPNT) intervention, followed by 7 night washout, then one night of HSAT only |
|
| Group 2 | Experimental | One night of HSAT only, followed by 7 night washout, then one night of HSAT with NPNT intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Negative Pressure Neck Therapy (NPNT) | Device | Negative pressure neck therapy (NPNT) is a self-contained, non-invasive, soft, flexible, external neck collar |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 night |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Research Manager | Contact | 6048754111 | 62500 | Shelley.Abercromby@vch.ca |
| Name | Affiliation | Role |
|---|---|---|
| John A Fleetham, MD | VCHA/UBC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Lung Health | Vancouver | British Columbia | V5Z 1M9 | Canada |
This is a pilot study, so only IPD used in the results publication may be shared in the future.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D012893 | Sleep Wake Disorders |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. | 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 | 1 night |
| 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 | 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) | 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 | 1 night |
| Participant Feedback on NPNT device comfort, usability and function based on the Device Evaluation Questionnaire using a Likert scale | 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 | 1 night |
| Participant Feedback on NPNT device based on qualitative data (open comments) from the Device Evaluation Questionnaire after the NPNT device intervention 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) | 1 night |
| 8 nights |
| Leon Judah Blackmore Centre for Sleep Disorders | Vancouver | British Columbia | V6T 2B5 | Canada |
|
| D020920 |
| Dyssomnias |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |