Feasibility of Upper Airway Stimulation in OSA
ConditionObstructive Sleep Apnoea (OSA)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorNotos Medical Limited
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Non-invasive electrical stimulation
DeviceThe 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.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Non-invasive electrical stimulation of the upper airwayExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Tolerability of non-invasive electrical stimulation of the upper airway during sleep
The proportion of participants who are able to tolerate 80% of their maximum awake tolerated dose during sleep.
Time frame
Night 1Secondary outcomes
1
Arousals
Number of arousals during sleep when patient is undergoing non-invasive electrical stimulation of the upper airway during respiratory events.
Time frame
Night 12
Subjective awareness of stimulation during sleep
Number of actual stimulation events compared to number of events felt by the participant. Number of subjective events will be determined post-sleep.
Time frame
Night 1Other outcomes
1
Respiratory disturbance index
Number of arousals from respiratory events. Only arousals during which stimulation was initiated will be included.
Time frame
Baseline, Night 12
Apnoea-Hypopnoea Index
Number of apneas and hypopneas per hour of sleep.
Time frame
Baseline, Night 13
Oxygen desaturation index
Number of desaturations (drop in oxygen saturation \>3%) per hour of sleep
Time frame
Baseline, Night 14
Drug induced sleep endoscopy
The VOTE classification system defines the degree of upper airway collapse at the level of the Velum (V), Oropharynx (O), Tongue (T) and Epiglottis (E). Collapse will be defined as either complete obstruction (2), partial obstruction (1) or no obstruction (0) at each level, and the pattern of collapse will be described at each level (antero-posterior for VTE, lateral for VOE, or concentric for V). Scoring will be conducted by three Investigators blinded to treatment allocation (i.e. baseline or with electrical stimulation). The three expert Investigators will review and come to consensus on scoring for each video.
Time frame
Day 3Sponsors and contacts
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Source ClinicalTrials.gov