Back to resultsComparison Between Natural Sleep Endoscopy and Drug-induced Sleep Endoscopy in Patients With Obstructive Sleep Apnea
Primary Purpose
Sleep Apnea, Obstructive, Sleep Apnea, Sleep Apnea Syndromes
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Drug-induced sleep endoscopy
Natural sleep endoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Sleep Apnea, Obstructive focused on measuring Sleep endoscopy, Sedation, Airflow analysis
Eligibility Criteria
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
Sites / Locations
- Antwerp University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Natural sleep
Drug-induced sleep
Arm Description
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 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.
Outcomes
Primary Outcome Measures
Endoscopic Classification System
Comparison of the frequencies of the site, gradation and pattern of upper airway collapse between natural and drug-induced sleep endoscopy.
Secondary Outcome Measures
Flow shape analysis
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
Acoustic analyses measured during both natural and drug-induced sleep endoscopy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04729478
Brief Title
Comparison Between Natural Sleep Endoscopy and Drug-induced Sleep Endoscopy in Patients With Obstructive Sleep Apnea
Official Title
Comparison Between Natural Sleep Endoscopy and Drug-induced Sleep Endoscopy in Patients With Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 30, 2021 (Actual)
Primary Completion Date
August 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
ethisch.comite@uza.be
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
Sleep endoscopy, Sedation, Airflow analysis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Blinded, prospective, single-center, comparative cohort study.
Masking
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.
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Natural sleep
Arm Type
Other
Arm Description
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.
Arm Title
Drug-induced sleep
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Drug-induced sleep endoscopy
Other Intervention Name(s)
DISE
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Natural sleep endoscopy
Other Intervention Name(s)
NSE
Intervention Description
Endoscopy during natural sleep.
Primary Outcome Measure Information:
Title
Endoscopic Classification System
Description
Comparison of the frequencies of the site, gradation and pattern of upper airway collapse between natural and drug-induced sleep endoscopy.
Time Frame
Immediately, during the procedure
Secondary Outcome Measure Information:
Title
Flow shape analysis
Description
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.
Time Frame
Immediately, during the procedure
Title
Acoustic analysis
Description
Acoustic analyses measured during both natural and drug-induced sleep endoscopy
Time Frame
Immediately, during the procedure
Other Pre-specified Outcome Measures:
Title
Apnea-hypopnea index (AHI)
Description
The AHI is an index of sleep apnea severity that encompasses the frequency of apneas (cessations in breathing) and hypopneas (reductions in airflow).
Time Frame
Immediately, during polysomnography
Title
Oxygen desaturation index (ODI)
Description
The ODI represents the average number of desaturation episodes (≥3%) per hour sleep.
Time Frame
Immediately, during polysomnography
Title
Oxygen saturation (SaO2)
Description
Minimal and mean SaO2 (%)
Time Frame
Immediately, during polysomnography
Title
Apnea index
Description
The apnea index is an index of sleep apnea severity that encompasses the frequency of apneas.
Time Frame
Immediately, during polysomnography
Title
Arousal index
Description
The arousal index is an indirect indicator of sleep apnea severity that encompasses the number of arousals related to total sleep time.
Time Frame
Immediately, during polysomnography
Title
Arousal threshold
Description
The occurrence of arousal from sleep with a rise in ventilatory drive.
Time Frame
Immediately, during polysomnography
Title
Daytime sleepiness measured with the Epworth Sleepiness Scale (ESS)
Description
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.
Time Frame
Immediately, before the procedure
Title
Checklist Individual Strength questionnaire (CIS20R) for fatigue
Description
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).
Time Frame
Immediately, before the procedure
Title
Snoring intensity measured with a Visual Analogue Scale (VAS)
Description
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.
Time Frame
Immediately, before the procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karlien Van den Bossche, MD
Phone
38212173
Ext
+32
Email
karlien.vandenbossche@uza.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier Vanderveken, MD, PhD
Organizational Affiliation
University Hospital, Antwerp
Official's Role
Principal Investigator
Facility Information:
Facility Name
Antwerp University Hospital
City
Edegem
State/Province
Antwerp
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karlien Van den Bossche, MD
Phone
38212173
Ext
+32
Email
karlien.vandenbossche@uza.be
First Name & Middle Initial & Last Name & Degree
Olivier Vanderveken, MD, PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
34950101
Citation
Van den Bossche K, Van de Perck E, Wellman A, Kazemeini E, Willemen M, Verbraecken J, Vanderveken OM, Vena D, Op de Beeck S. Comparison of Drug-Induced Sleep Endoscopy and Natural Sleep Endoscopy in the Assessment of Upper Airway Pathophysiology During Sleep: Protocol and Study Design. Front Neurol. 2021 Dec 7;12:768973. doi: 10.3389/fneur.2021.768973. eCollection 2021.
Results Reference
derived
Learn more about this trial
Comparison Between Natural Sleep Endoscopy and Drug-induced Sleep Endoscopy in Patients With Obstructive Sleep Apnea
We'll reach out to this number within 24 hrs