Clinical trial NCT02324790: Pilot Study of Negative Pressure Sleep Therapy System to Treat Obstructive Sleep Apnea
Official title: A Multicenter Pilot Study on the Indications of Negative Pressure Sleep Therapy System for the Treatment of Obstructive Sleep Apnea (OSA)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: OSA, Oral Pressure Therapy (OPT)
Lead sponsor: Somnics, Inc.
Sponsor class: INDUSTRY
First posted: 2014-12-24
Enrollment: 34
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of OSA, based on AHI 10\~60 (as assessed per baseline PSG).
* Subject understands the study protocol and is willing and able to comply with study requirements and sign the informed consent form.
* BMI ≦ 28.

Exclusion Criteria:

* Poor nasal patency as evidenced by the inability to breathe through the nose with the mouth closed.
* Oral cavity infection or any other oral or dental condition or problem that would limit subject use of the device. (e.g. dentures, loose tooth/teeth, temporomandibular joint (TMJ) conditions, or any oral or dental condition that the Investigator believes could be exacerbated by the Sleep Therapy System.
* History of any OSA surgical treatment including uvulopalatopharyngoplasty surgery (UPPP), maxillomandibular advancement surgery (MMA), radio frequency (RF) ablation treatment, palatal stent devices, etc.
* History of allergic reaction to silicone.
* Any concomitant diagnosed or suspected sleep or chronic neurological disorders, other than OSA, including insomnia, and central sleep apnea.
* Currently working nights, rotating night shifts, planned travel across four or more time zones required during study period, or within two weeks prior to study enrollment, or sleep schedule not compatible with sleep lab practices.
* Current use of medication or other treatment which, in the investigator's opinion, may pose additional risk to the subject or confound the results of the study.
* Potential sleep apnea complications that, in the opinion of the investigator, may affect the health or safety of the participant, including: low blood oxygen, recent near-miss or prior automobile accident due to sleepiness, reported history of severe cardiovascular disease (including New York Heart Association (NYHA) class III or IV heart failure, CAD with angina or myocardial infarction (MI)/stroke in past 6 months, uncontrolled hypertension or hypotension, cardiac arrhythmias), reported respiratory disorders, or use of medication or other treatment which may pose additional risk to the subject or confound the results of the study.
* Female subjects who are pregnant or intend to become pregnant during the study period.

Primary outcomes:
measure: Change from baseline of Apnea-Hypopnea Index (AHI)
timeFrame: One treatment night
Secondary outcomes:
measure: Change from baseline of obstructive apnea reduction
timeFrame: One treatment night
measure: Change from baseline of oxygen desaturation index (ODI)
timeFrame: One treatment night
measure: Adverse event (AE)/ serious adverse event (SAE) rate and type
timeFrame: From informed consent form obtained to the end of study, average of 4 weeks
Other outcomes:
Locations:
city: Hsinchu
country: Taiwan
facility: Mackay Memorial Hospital, Hsinchu
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taipei
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Shin Kong Wu Ho-Su Memorial Hospital
name: C.M. Lin, M.D.
role: PRINCIPAL_INVESTIGATOR
References: