Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Project Breathe 1 | Other Identifier | Notos Medical Limited |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-invasive electrical stimulation of the upper airway | Experimental | Participants will have bilateral non-invasive electrical stimulation of the submandibular region while undergoing a polysomnography assessment and during drug induced sleep endoscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-invasive electrical stimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Night 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Arousals | Number of arousals during sleep when patient is undergoing non-invasive electrical stimulation of the upper airway during respiratory events. | Night 1 |
| Subjective awareness of stimulation during sleep |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory disturbance index | Number of arousals from respiratory events. Only arousals during which stimulation was initiated will be included. | Baseline, Night 1 |
| Apnoea-Hypopnoea Index | Number of apneas and hypopneas per hour of sleep. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Johan Verbraecken | Universiteit Antwerpen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antwerp University Hospital | Recruiting | Edegem | 2650 | Belgium |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
Not provided
Not provided
Not provided
Not provided
Not provided
Assessors scoring the drug induced sleep endoscopy VOTE videos will be blinded to the treatment provided.
Not provided
|
Number of actual stimulation events compared to number of events felt by the participant. Number of subjective events will be determined post-sleep.
| Night 1 |
| Baseline, Night 1 |
| Oxygen desaturation index | Number of desaturations (drop in oxygen saturation >3%) per hour of sleep | Baseline, Night 1 |
| 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. | Day 3 |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |