Negative Pressure Neck Therapy for Sleep Apnea

Not yet recruiting at 1 trial location
RM
Overseen ByResearch Manager
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of British Columbia
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

JA

John A Fleetham, MD

Principal Investigator

VCHA/UBC

Are You a Good Fit for This Trial?

This trial is for individuals with a body mass index (BMI) of 42 or less who can speak, read, and write English. It's designed to help those suffering from sleep apnea disorders by testing a new therapy called NPNT.

Inclusion Criteria

My BMI is 42 or less.
I can speak, read, and write in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Acclimatization

Participants undergo a 7-day acclimatization period to the NPNT device

1 week
1 phone call

Treatment

Participants use the NPNT device during one night of home sleep apnea testing

1 night
1 visit (in-person)

Washout

A 7-night washout period between intervention nights

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Negative Pressure Neck Therapy (NPNT)

Trial Overview

The study tests Negative Pressure Neck Therapy (NPNT) on up to 10 healthy participants to see if it's safe and effective for treating obstructive sleep apnea. Participants will use the NPNT device during one of two home sleep tests conducted about a week apart.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Group 2Experimental Treatment1 Intervention
Group II: Group 1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials
1,506
Recruited
2,528,000+

Vancouver Coastal Health Research Institute

Collaborator

Trials
30
Recruited
5,600+