Obstructive Sleep Apnoea (OSA)
Conditions
Keywords
obstructive sleep apnoea, OSA, sleep apnoea
Brief summary
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.
Interventions
DEVICENon-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.
Sponsors
Notos Medical Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Assessors scoring the drug induced sleep endoscopy VOTE videos will be blinded to the treatment provided.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability of non-invasive electrical stimulation of the upper airway during sleep | Night 1 | The proportion of participants who are able to tolerate 80% of their maximum awake tolerated dose during sleep. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Arousals | Night 1 | Number of arousals during sleep when patient is undergoing non-invasive electrical stimulation of the upper airway during respiratory events. |
| Subjective awareness of stimulation during sleep | Night 1 | Number of actual stimulation events compared to number of events felt by the participant. Number of subjective events will be determined post-sleep. |
Countries
Belgium
Contacts
PRINCIPAL_INVESTIGATORJohan Verbraecken
Universiteit Antwerpen
Outcome results
None listed