Evaluation of the response of sleeping obstructive sleep apnea (OSA) patients to electrical stimulation of the inner branch of the laryngeal superior nerve (iSLN)

Recruitment & Eligibility

Status: Recruiting

Sex: Male

Target Recruitment: 80

Inclusion Criteria

• Age = 18 years
• Male subjects with a previous clinical diagnosis of obstructive sleep apnoea
• AHI between 15 and 30
• BMI = 35
• High motivation with realistic expectations regarding the participation in this study
• Anatomic, physiological and mental conditions compatible with the participation in this study
• Signed and dated informed consent before the start of any study-specific procedure.

Exclusion Criteria

• Lack of compliance with any inclusion criteria
• Use of recreational drugs
• Heavy smoker in past 2 years
• Wearing an implantable active device (e.g. heart pacemaker)
• Other clinical diseases that might result in sleep alterations: e.g. COPD, other pulmonary diseases, heart failure, other cardiac diseases, Cheyne-Stokes respiration, thyroid disease, psychiatric disorders, alcoholism or drug abuse, use of sleep inducing medications, epilepsy, hypoventilation syndrome, insomnia, narcolepsy, night terrors, parasomnias, nocturia, rhythmic movement disorder (RMD), periodic limb movement disorder (PLMS), or other neurological disorders
• Infection of the upper airway or nasal congestion
• Previous history of dysphagia or other swallowing disorders, laryngospasm, cancer of the head or neck
• Tracheostomy, UPPP, or other surgical intervention for apnoea with the exclusion of nose-related surgeries, tonsillectomies and/or adenoidectomies
• Concomitant use of propranolol, sulpiride, carbamazepine, dextromethorphan, sleep aids, or other current medications known to interfere with sleep, swallow, or breathing
• Nose, mouth or head injuries
• Bleeding disorders, clotting problems, use of anticoagulants
• Known allergies or intolerance to the material used for this study
• Current participation in other drugs and/or medical device studies that can affect the results of the present trial
• Anything that, in the opinion of the Principal Investigator, would place the subject at increased risk or preclude the subject's full compliance with the general requirements of this study

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary aim of this study to evaluate the possibility to induce a negative pressure reflex in sleeping OSA patients by iSLN electrical stimulation in order to reduce the patients’ AHI. The maximal duration of the clinical investigation are 2 nights. Screening and informed consent (2 hours; performed once at the very beginning of the clinical investigation), awake titration (1 hour x 2 nights), control night (1 night), stimulation night (1 night). The stimulation bursts will be regularly delivered for the entire testing night and will start earliest 30 min after the subject reaches the light sleep stage.

Secondary Outcome Measures

Name	Time	Method
The secondary objectives of this clinical investigation are to determine the number of OSA events in NREM vs. REM and to evaluate the response of additional parameters routinely collected through a standard PSG to the stimulation:<br><br>• Apnoe-Hypopnoe-Index (AHI)<br>• RDI (Respiratory disturbance index)<br>• Arousals<br>• Snoring<br>• PLM (periodic limb movements)<br>• WASO (wake after sleep onset)<br>• TIB (time in bed)<br>• TST (total sleep time)<br>• SEI (sleep efficiency index)<br>• SpO2 TST<br>• Sleep position<br>• Duration of the various sleep stage in TST:<br>• Stage W: Wakefulness<br>• Stage N1: Relaxed Wakefulness<br>• Stage N2: Light Sleep<br>• Stage N3: Deep Sleep or Slow-Wave Sleep (SWS)<br>• Stage R: REM Sleep (Dreaming)<br><br>The secondary objectives will be evaluated only descriptively and thus they won’t contribute to determine the success or the failure of the clinical investigation, according to the pre-set hypotheses.