Apnea, Central Nervous System Depressants, Dyssomnia, General Anesthetics, Hypnotics and Sedatives, Midazolam, Nervous System Diseases, Physiological Effects of Drugs, Propofol, Respiration Disorder, Respiratory Tract Disease, Sleep Apnea, Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Sleep Disorders, Intrinsic, Sleep Wake Disorders
Conditions
Keywords
Sleep endoscopy, Sedation, Airflow analysis
Brief summary
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).
Detailed description
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.
Interventions
An intravenous bolus injection of midazolam 1.5 mg will be used to induce sleep. Maintenance of sedated sleep will be obtained by a target-controlled infusion of propofol (2.0-3.0 µg/mL).
DEVICENatural sleep endoscopy
Endoscopy during natural sleep.
Sponsors
ethisch.comite@uza.be
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Masking description
NSE and DISE will be performed by two separate researchers, blinding the ENT surgeon who performs the NSE or DISE for the outcome of the other procedure. This is a blinded study and the researchers will have no knowledge of the patient's characteristics / demographic variables and their history.
Intervention model description
Blinded, prospective, single-center, comparative cohort study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endoscopic Classification System | Immediately, during the procedure | Comparison of the frequencies of the site, gradation and pattern of upper airway collapse between natural and drug-induced sleep endoscopy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Flow shape analysis | Immediately, during the procedure | Several parameters extracted from the flow signal, including negative effort dependence (NED), peak inspiratory flow, etc. measured during both natural and drug-induced sleep endoscopy. |
| Acoustic analysis | Immediately, during the procedure | Acoustic analyses measured during both natural and drug-induced sleep endoscopy |
Other
| Measure | Time frame | Description |
|---|---|---|
| Apnea index | Immediately, during polysomnography | The apnea index is an index of sleep apnea severity that encompasses the frequency of apneas. |
| Arousal index | Immediately, during polysomnography | The arousal index is an indirect indicator of sleep apnea severity that encompasses the number of arousals related to total sleep time. |
| Arousal threshold | Immediately, during polysomnography | The occurrence of arousal from sleep with a rise in ventilatory drive. |
| Apnea-hypopnea index (AHI) | Immediately, during polysomnography | The AHI is an index of sleep apnea severity that encompasses the frequency of apneas (cessations in breathing) and hypopneas (reductions in airflow). |
| Checklist Individual Strength questionnaire (CIS20R) for fatigue | Immediately, before the procedure | The checklist individual strength (CIS20R) is a 20-item questionnaire to assess the degree of fatigue. The patient selects the most appropriate score on each statement ranging from 1 (yes, this is true) to 7 (no, this is not true). The total score, calculated as the sum of the questions, may yield to a maximum of 140. The CIS20R measures four dimensions of fatigue: fatigue severity (8 items), concentration problems (5 items), reduced motivation (4 items) and activity (3 items). |
| Snoring intensity measured with a Visual Analogue Scale (VAS) | Immediately, before the procedure | The subjective degree of snoring during sleep will be evaluated by the partner of a subject by using a VAS scoring system ranging from 0 (no snoring) to 10 (extreme snoring causing the bed partner to sleep separately). Heavy snoring is determined as a snoring index ≥7. |
| Daytime sleepiness measured with the Epworth Sleepiness Scale (ESS) | Immediately, before the procedure | The probability of falling asleep in various settings and situations in daily life will be assessed. This questionnaire consists of eight questions which can be scored on a four-point Likert-type scale. The lowest score (zero) suggests that the described incident is absent and the highest score (three) suggests the presence of this event. The summation of the eight items can range from 0 to 24. |
| Oxygen desaturation index (ODI) | Immediately, during polysomnography | The ODI represents the average number of desaturation episodes (≥3%) per hour sleep. |
| Oxygen saturation (SaO2) | Immediately, during polysomnography | Minimal and mean SaO2 (%) |
Countries
Belgium
Contacts
Primary ContactKarlien Van den Bossche, MD
Outcome results
None listed