RECRUITINGINTERVENTIONAL
Feasibility of Upper Airway Stimulation in OSA
Feasibility of Non-invasive Electrical Nerve Stimulation of the Upper Airway in Patients With Obstructive Sleep Apnoea
About This Trial
Project Breathe 1 is a short-duration (5 month) pilot investigation to assess the safety and tolerability of non-invasive electrical stimulation in adults with obstructive sleep apnoea. The investigation is an unblinded, uncontrolled, single arm design.
Who May Be Eligible (Plain English)
Who May Qualify:
- Obstructive sleep apnoea diagnosis with an AHI of 15-50 events/hour recorded in the baseline polysomnography (PSG)
- BMI \< 32 kg/m²
- Age \> 18 years old
- Able to read, write, and speak Dutch with acceptable visual and auditory acuity
- Able and willing to provide willing to sign a consent form
Who Should NOT Join This Trial:
- Presence of a cardiac pacemaker or implantable cardiac defibrillator or ventriculoperitoneal shunt
- Central (non-obstructive) AHI episodes \>5 events/hour recorded in the baseline PSG
- Inability to sleep supine
- Pregnancy
- Inability to undergo DISE
- Inability or unwillingness to shave under and around their chin and neck if appropriate
- Known inability to complete PSG with a total sleep time of \> 4 hours
- The use of other neurostimulatory devices
- A diagnosis of periodic leg movement disorder
- Awake resting arterial oxygen saturation \<93% (suggesting possible hypoventilation)
- Unstable, untreated coronary or peripheral artery disease
- Severe arterial hypertension defined as a resting blood pressure (BP) of \>180/110mmHg
- Currently employed as a professional driver
- Any previous sleep-related driving accident
- A past or current condition that in the opinion of the investigator contraindicates enrolment (e.g. chronic substance abuse, severe psychiatric disorders)
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Obstructive sleep apnoea diagnosis with an AHI of 15-50 events/hour recorded in the baseline polysomnography (PSG)
* BMI \< 32 kg/m²
* Age \> 18 years old
* Able to read, write, and speak Dutch with acceptable visual and auditory acuity
* Able and willing to provide informed consent
Exclusion Criteria:
* Presence of a cardiac pacemaker or implantable cardiac defibrillator or ventriculoperitoneal shunt
* Central (non-obstructive) AHI episodes \>5 events/hour recorded in the baseline PSG
* Inability to sleep supine
* Pregnancy
* Inability to undergo DISE
* Inability or unwillingness to shave under and around their chin and neck if appropriate
* Known inability to complete PSG with a total sleep time of \> 4 hours
* The use of other neurostimulatory devices
* A diagnosis of periodic leg movement disorder
* Awake resting arterial oxygen saturation \<93% (suggesting possible hypoventilation)
* Unstable, untreated coronary or peripheral artery disease
* Severe arterial hypertension defined as a resting blood pressure (BP) of \>180/110mmHg
* Currently employed as a professional driver
* Any previous sleep-related driving accident
* A past or current condition that in the opinion of the investigator contraindicates enrolment (e.g. chronic substance abuse, severe psychiatric disorders)
Treatments Being Tested
DEVICE
Non-invasive electrical stimulation
The non-invasive electrical stimulation components will consist of two Digitimer DS5 isolated current stimulators, voltage control by an NI-9262 module, and two pairs of adhesive electrodes placed in the submandibular region.
Locations (1)
Antwerp University Hospital
Edegem, Belgium