This is a pilot study to investigate the efficacy and safety of the Negative Pressure Sleep Therapy System for the treatment of obstructive sleep apnea.
This is an open-lable, single-arm, evaluator-blind and prospective study aimed to evaluate the feasibility of the Negative Pressure Sleep Therapy System for the treatment of obstructive sleep apnea.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
The iNAP® Sleep Therapy System provides pressure gradient within the oral cavity to pull the tongue toward upper palate and the soft palate forward, which aims to maintain better upper airway patency near the pharynx to prevent sleep-disordered breathing.
Mackay Memorial Hospital, Hsinchu
Hsinchu, Taiwan
China Medical University Hospital
Taichung, Taiwan
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Change from baseline of Apnea-Hypopnea Index (AHI)
The study was terminated. No enough samples for statistical analysis.
Time frame: One treatment night
Change from baseline of obstructive apnea reduction
The study was terminated. No enough samples for statistical analysis.
Time frame: One treatment night
Change from baseline of oxygen desaturation index (ODI)
The study was terminated. No enough samples for statistical analysis.
Time frame: One treatment night
Adverse event (AE)/ serious adverse event (SAE) rate and type
During the entire study period, a total of only 9 events were reported by 8 patients.
Time frame: From informed consent form obtained to the end of study, average of 4 weeks
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