Pilot Study of Negative Pressure Neck Therapy (NPNT)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorUniversity of British Columbia
About 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.
Eligibility criteria
Qualifiers
Body mass index ≤42 kg/m2
Able to speak, read, and write English
Disqualifiers
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
Trial design
Treatments tested in this trial
- Negative Pressure Neck Therapy (NPNT)
Treatment groups
10 Participants
are divided into 2 treatment groupsLocations
2Centre for Lung HealthV5Z 1M9, VancouverBritish Columbia, Canada
Leon Judah Blackmore Centre for Sleep DisordersV6T 2B5, VancouverBritish Columbia, Canada
Sponsors and collaborators
University of British Columbia
Lead sponsor
Vancouver Coastal Health Research Institute
Collaborator
Source ClinicalTrials.gov