| Registry | NCT04729478 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; non randomized, single group, masking: single, diagnostic |
| Enrollment | 40 (Estimated) |
| Sponsor | ethisch.comite@uza.be (Other) |
| Conditions | Sleep Apnea, Obstructive, Sleep Apnea, Sleep Apnea Syndromes, Apnea, Respiration Disorder, Respiratory Tract Disease, Dyssomnia, Sleep Disorders, Intrinsic, Sleep Wake Disorders, Nervous System Diseases, Hypnotics and Sedatives, Central Nervous System Depressants, Propofol, Midazolam, Physiological Effects of Drugs, General Anesthetics |
| Interventions | Drug-induced sleep endoscopy, Natural sleep endoscopy (Device) |
| Dates | start 2021-03-30, primary completion 2022-08-31 (estimated), completion 2022-12-31 (estimated), first posted 2021-01-28, last updated 2021-07-26 |
| Locations | 1 site in Belgium |
Related Papers Related Patents Related Grants Related Experts
All trials for Sleep Apnea, Obstructive All trials for Sleep Apnea All trials of Drug-induced sleep endoscopy All trials of Natural sleep endoscopy
Drug-induced sleep endoscopy (DISE) is the most used technique for identifying the obstruction site associated with obstructive sleep apnea (OSA). This is due to the fact that it allows many patients to be examined in a daytime setting. This procedure uses sedative drugs to mimic natural sleep. However, associations with the site of upper airway (UA) collapse during natural sleep remain unclear.
The aim of this explorative study is to identify UA collapse in patients with OSA using endoscopic techniques as well as flow shape characteristics and sound analyses during natural and drug-induced sleep. Furthermore, we want to optimize the measurement set-up of natural sleep endoscopy (NSE).
Patients with moderate to severe OSA requiring DISE will be recruited for this prospective study at the outpatient clinic. Patients will undergo a NSE at the sleep lab at night, and a DISE at the operating theatre within three months. Both the NSE and DISE set-up will include gold-standard flow measurements, acoustic analysis and esophageal pressure measurements.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Natural sleep | Other | Device: Natural sleep endoscopy | Natural sleep endoscopy (NSE) OSA patients will be endoscopically evaluated during natural sleep. During NSE additional physiological measurements (flow shape analysis, acoustic analysis of snoring sounds and esophageal pressure measurements) will be carried out. |
| Drug-induced sleep | Other | Device: Drug-induced sleep endoscopy | Drug-induced sleep endoscopy (DISE) OSA patients will be endoscopically evaluated during drug-induced sleep. During DISE additional physiological measurements (flow shape analysis, acoustic analysis of snoring sounds and esophageal pressure measurements) will be carried out. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * Diagnosis of OSA with a baseline AHI ≥ 15 per hour based on full polysomnography * Body mass index (BMI) ≤ 35 kg/m² * Capability of giving informed consent and willingness to undergo NSE Exclusion Criteria: * Central sleep apnea (defined as CAHI ≥ 30% of total AHI) * Inability to sleep in a supine position due to a medical condition * Inability of the patient to understand and/or comply to the study procedures * Neuromuscular disorders or craniofacial anomalies affecting the UA * Sedative medication use (opioids and muscle relaxants) * Active psychiatric disorders (psychotic illness, major depression, anxiety attacks, excessive alcohol or drug use) * Severe or decompensated cardiac or respiratory diseases * Medical history of known causes of tiredness by day or severe sleep disruption (insomnia, PLMS, narcolepsy) * Contra-indications for DISE: i.e. fitness for general anesthesia (ASA>3), allergy to sedative agent(s) and an expected extremely difficult airway * Pregnancy or willing to become pregnant
| Facility | City | Country | Status |
|---|---|---|---|
| Antwerp University Hospital | Edegem, Antwerp | Belgium | Recruiting |