Sleep Apnea, ObstructiveNCT04729478
Comparison Between Natural Sleep Endoscopy and Drug-induced Sleep Endoscopy in Patients With Obstructive Sleep Apnea
A study testing Drug-induced sleep endoscopy and Natural sleep endoscopy in people with Sleep Apnea, Obstructive and Sleep Apnea, run by ethisch.comite@uza.be at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive, Sleep Apnea, Sleep Apnea Syndromes
- What is being tested?
- Drug-induced sleep endoscopy and Natural sleep endoscopy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 30 Mar 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Antwerp University Hospital
Edegem, Antwerp, 2650
Karlien Van den Bossche, MD, 38212173 ext. +32, karlien.vandenbossche@uza.be
Olivier Vanderveken, MD, PhD
About this study
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).
Read the 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.
- Conditions
- Sleep Apnea, Obstructive, Sleep Apnea, Sleep Apnea Syndromes, Apnea, Respiration Disorder, Respiratory Tract Disease
- Being tested
- Drug-induced sleep endoscopy, Natural sleep endoscopy
- Keywords
- Sleep endoscopy, Sedation, Airflow analysis
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Apnea, Respiration Disorders, Respiratory Tract Diseases, Dyssomnias, Sleep Disorders, Intrinsic, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug-induced sleep endoscopyDevice
Also called DISE
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).
Natural sleep endoscopyDevice
Also called NSE
Endoscopy during natural sleep.
| Study group | Role | What they receive |
|---|---|---|
| Natural sleep | Other | 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. Receives: Device: Natural sleep endoscopy |
| Drug-induced sleep | Other | 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. Receives: Device: Drug-induced sleep endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoscopic Classification System
Comparison of the frequencies of the site, gradation and pattern of upper airway collapse between natural and drug-induced sleep endoscopy.
Measured: Immediately, during the procedure
Secondary outcomes (2)
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.
Measured: Immediately, during the procedure
Acoustic analysis
Acoustic analyses measured during both natural and drug-induced sleep endoscopy
Measured: Immediately, during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start30 Mar 2021
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Blinded, prospective, single-center, comparative cohort study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ethisch.comite@uza.be
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ethisch.comite@uza.be, University Hospital, Antwerp
- Investigators
- Olivier Vanderveken, MD, PhD, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04729478
- Sponsor's protocol ID
- B3002021000006
- Status last verified
- Jul 2021
- First submitted
- 26 Jan 2021
- Last updated
- 26 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34950101
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Natural Sleep Endoscopy and Drug-induced Sleep Endoscopy in Patients With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT04729478
- Acronym / sponsor ID
- B3002021000006
- Conditions
- Sleep Apnea, Obstructive, Sleep Apnea, Sleep Apnea Syndromes, Apnea, Respiration Disorder, Respiratory Tract Disease
- Keywords
- Sleep endoscopy, Sedation, Airflow analysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- ethisch.comite@uza.beUniversity, hospital or other
- Study start
- 30 Mar 2021 (actual)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 28 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Blinded, prospective, single-center, comparative cohort study.
| Arm | Type | Receives |
|---|---|---|
| Natural sleep | Other | Device: Natural sleep endoscopyNatural 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 endoscopyDrug-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug-induced sleep endoscopyAlso: DISEAn 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). | Device | Drug-induced sleep |
| Natural sleep endoscopyAlso: NSEEndoscopy during natural sleep. | Device | Natural sleep |
Primary outcome
Endoscopic Classification System
Time frame: 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.
2 secondary outcomes
Flow shape analysis
Time frame: Immediately, during the procedure
Acoustic analysis
Time frame: Immediately, during the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2021.
- Derived from this study: PubMed 34950101Van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Vanderveken, MD, PhD principal investigator
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug-induced sleep endoscopy and Natural sleep endoscopy in people with Sleep Apnea, Obstructive and Sleep Apnea, run by ethisch.comite@uza.be at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karlien Van den Bossche, MD (38212173 ext. +32, karlien.vandenbossche@uza.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endoscopic Classification System (time frame: Immediately, during the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04729478, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2021.