Obstructive Sleep ApneaNCT03004014
Natural Sleep and Drug-induced Sleep Endoscopy
A study testing Sleep endoscopy during propofol induced sleep in people with Obstructive Sleep Apnea, run by Pedro Rodrigues Genta at 1 site in Brazil.
Trial summary
Drug induced sleep endoscopy (DISE) has been performed worldwide since 1991 to determine the site and configuration of upper airway obstruction in patients with obstructive sleep apnea (OSA). However, there are no studies comparing DISE to sleep endoscopy during natural sleep. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Sleep endoscopy during propofol induced sleep
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2015to Jan 2018
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI less than 35kg/m2
- Apnea-hypopnea index > 5 events/hour of sleep
- Clinical indication of surgical treatment for sleep apnea
Who cannot join
- Severe or decompensated cardiac or respiratory diseases
- Previous pharyngeal surgery
- Tonsils grade III or IV
- Other sleep disturbance (parasomnias, primary insomnia, narcolepsy)
- Sedative medication use (opioids, benzodiazepines and muscle relaxants)
- Uncontrolled diabetes or hyperthyroidism
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo
São Paulo, São Paulo, 05403900
About this study
Official title: Comparison Between Natural Sleep Endoscopy and Drug-induced Sleep Endoscopy Among Obstructive Sleep Apnea Subjects Referred for Surgical Treatment
Drug induced sleep endoscopy (DISE) has been performed worldwide since 1991 to determine the site and configuration of upper airway obstruction in patients with obstructive sleep apnea (OSA). However, there are no studies comparing DISE to sleep endoscopy during natural sleep. Objectives: To compare DISE to natural sleep endoscopy in OSA patients referred for surgical treatment.
Methods: OSA patients referred to surgical treatment (lateral pharyngoplasty) will be enrolled in this study. Natural sleep endoscopy will be performed at the sleep lab during the night. Propofol induced sleep will be performed at the operating room before surgery. The VOTE (velum, oropharyngeal lateral walls, tongue base and epiglottis) classification will be used to compare site and configuration of collapse between studies. Peak inspiratory flow will also be compared between studies.
Read the detailed description
Drug induced sleep endoscopy (DISE) has been performed worldwide since 1991 to determine the site and configuration of upper airway obstruction in patients with obstructive sleep apnea. However, there are no studies comparing DISE to sleep endoscopy during natural sleep. Objective: to compare natural sleep endoscopy to drug induced sleep with propofol.
The study population will include 28 patients who are candidates to surgical treatment.
Methods Detailed clinical history and physical examination will be performed before natural sleep endoscopy. A 2-hour fast will be required. During both natural sleep and propofol-induced sleep, pharyngeal pressure will be measured using a pressure-tipped catheter (model TC-500XG; Millar).The nasopharynx will be numbed with xylocaine (10%) and oxymetazoline (0.05%), the catheter will be passed through a nasal mask into one nostril, and placed at the tongue base as confirmed by visual inspection of the oropharynx.A 2.8mm pediatric bronchoscope (Olympus) will be passed through the mask and into the other nostril. A nasal mask will be fitted and a heated pneumotachograph with differential pressure transducer connected to the mask will quantify airflow. The endoscope will be located at velopharynx, lateral wall of the pharynx and 2 cm above tongue and epiglottis.The VOTE Endoscopic Classification will be used to describe site and configuration of pharyngeal collapse in each study. The study will be scored by two experienced investigators, blind to the patient identification and type of study (natural sleep or drug-induced). Propofol-induced sleep will be performed at the operating room before surgery.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Sleep endoscopy during propofol induced sleep
- Keywords
- sleep endoscopy, sedation
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep endoscopy during propofol induced sleepOther
It will be performed a sleep endoscopy during drug induced sleep endoscopy
| Study group | Role | What they receive |
|---|---|---|
| Natural Sleep | No intervention | OSA subjects referred for surgical treatment will evaluated endoscopically during natural sleep |
| Propofol Induced Sleep | Other | Sleep endoscopy during propofol induced sleep
OSA subjects referred for surgical treatment will be evaluated endoscopically during propofol induced sleep Receives: Other: Sleep endoscopy during propofol induced sleep |
What is being measured
The primary outcome is the main question the study is designed to answer.
The VOTE Endoscopic Classification
Comparison of site and configuration of endoscopy findings between the natural and drug-induced sleep endoscopy. The VOTE Endoscopic Classification describes the patterns and the degree of obstruction during sleep endoscopy.
Measured: Immediately, during the procedure
Secondary outcomes (1)
Peak inspiratory flow
Peak inspiratory flow 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 Dec 2016 (estimated)
- Study startJan 2015
- Primary completionDec 2017
- Study completionJan 2018
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 Obstructive Sleep ApneaStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pedro Rodrigues Genta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pedro Rodrigues Genta, University of Sao Paulo General Hospital
- Investigators
- Pedro R Genta, Post Doc, Principal investigator, Sleep Laboratoy, Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03004014
- Sponsor's protocol ID
- 13900
- Status last verified
- Jul 2018
- First submitted
- 4 Aug 2016
- Last updated
- 31 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Ordones AB, Grad GF, Cahali MB, Lorenzi-Filho G, Sennes LU, Genta PR. Comparison of upper airway obstruction during zolpidem-induced sleep and propofol-induced sleep in patients with obstructive sleep apnea: a pilot study. J Clin Sleep Med. 2020 May 15;16(5):725-732. doi: 10.5664/jcsm.8334. Epub 2020 Feb 7.
PubMed 32029070
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. 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 Among Obstructive Sleep Apnea Subjects Referred for Surgical Treatment
- ClinicalTrials.gov ID
- NCT03004014
- Acronym / sponsor ID
- 13900
- Conditions
- Obstructive Sleep Apnea
- Keywords
- sleep endoscopy, sedation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Pedro Rodrigues GentaUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 28 Dec 2016 (estimated)
- 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) has been performed worldwide since 1991 to determine the site and configuration of upper airway obstruction in patients with obstructive sleep apnea (OSA). However, there are no studies comparing DISE to sleep endoscopy during natural sleep. Objectives: To compare DISE to natural sleep endoscopy in OSA patients referred for surgical treatment.
Methods: OSA patients referred to surgical treatment (lateral pharyngoplasty) will be enrolled in this study. Natural sleep endoscopy will be performed at the sleep lab during the night. Propofol induced sleep will be performed at the operating room before surgery. The VOTE (velum, oropharyngeal lateral walls, tongue base and epiglottis) classification will be used to compare site and configuration of collapse between studies. Peak inspiratory flow will also be compared between studies.
Detailed description
Drug induced sleep endoscopy (DISE) has been performed worldwide since 1991 to determine the site and configuration of upper airway obstruction in patients with obstructive sleep apnea. However, there are no studies comparing DISE to sleep endoscopy during natural sleep. Objective: to compare natural sleep endoscopy to drug induced sleep with propofol.
The study population will include 28 patients who are candidates to surgical treatment.
Methods Detailed clinical history and physical examination will be performed before natural sleep endoscopy. A 2-hour fast will be required. During both natural sleep and propofol-induced sleep, pharyngeal pressure will be measured using a pressure-tipped catheter (model TC-500XG; Millar).The nasopharynx will be numbed with xylocaine (10%) and oxymetazoline (0.05%), the catheter will be passed through a nasal mask into one nostril, and placed at the tongue base as confirmed by visual inspection of the oropharynx.A 2.8mm pediatric bronchoscope (Olympus) will be passed through the mask and into the other nostril. A nasal mask will be fitted and a heated pneumotachograph with differential pressure transducer connected to the mask will quantify airflow. The endoscope will be located at velopharynx, lateral wall of the pharynx and 2 cm above tongue and epiglottis.The VOTE Endoscopic Classification will be used to describe site and configuration of pharyngeal collapse in each study. The study will be scored by two experienced investigators, blind to the patient identification and type of study (natural sleep or drug-induced). Propofol-induced sleep will be performed at the operating room before surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Natural Sleep | No intervention | –OSA subjects referred for surgical treatment will evaluated endoscopically during natural sleep |
| Propofol Induced Sleep | Other | Other: Sleep endoscopy during propofol induced sleepSleep endoscopy during propofol induced sleep OSA subjects referred for surgical treatment will be evaluated endoscopically during propofol induced sleep |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI less than 35kg/m2
- Apnea-hypopnea index > 5 events/hour of sleep
- Clinical indication of surgical treatment for sleep apnea
Key exclusion criteria (6 listed)
- Severe or decompensated cardiac or respiratory diseases
- Previous pharyngeal surgery
- Tonsils grade III or IV
- Other sleep disturbance (parasomnias, primary insomnia, narcolepsy)
- Sedative medication use (opioids, benzodiazepines 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 |
|---|---|---|
| Sleep endoscopy during propofol induced sleepIt will be performed a sleep endoscopy during drug induced sleep endoscopy | Other | Propofol Induced Sleep |
Primary outcome
The VOTE Endoscopic Classification
Time frame: Immediately, during the procedure
Comparison of site and configuration of endoscopy findings between the natural and drug-induced sleep endoscopy. The VOTE Endoscopic Classification describes the patterns and the degree of obstruction during sleep endoscopy.
1 secondary outcome
Peak inspiratory flow
Time frame: Immediately, during the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
- Derived from this study: PubMed 32029070Ordones AB, Grad GF, Cahali MB, Lorenzi-Filho G, Sennes LU, Genta PR. Comparison of upper airway obstruction during zolpidem-induced sleep and propofol-induced sleep in patients with obstructive sleep apnea: a pilot study. J Clin Sleep Med. 2020 May 15;16(5):725-732. doi: 10.5664/jcsm.8334. Epub 2020 Feb 7.
- Individual participant dataSharing planned: Yes
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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.
Pedro R Genta, Post Doc principal investigator
Sleep Laboratoy, Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep endoscopy during propofol induced sleep in people with Obstructive Sleep Apnea, run by Pedro Rodrigues Genta at 1 site in Brazil.
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 6 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: finished, as of the sponsor's last update on 31 Jul 2018. 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The VOTE Endoscopic Classification (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 NCT03004014, 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 31 Jul 2018.