Obstructive Sleep ApneaNCT03517150

Intraoral Appliance in the Treatment of Obstructive Sleep Apnea Syndrome in Obese

A study testing mandibular advancement device in people with Obstructive Sleep Apnea and Obesity, run by University of Sao Paulo.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

This study evaluates the effectiveness of intraoral appliance in the treatment of obstructive sleep Apnea Syndrome in class III obese in comparison to an adjustable silicone appliance. Both treatments will be test by all of the participants and they will make the polysomnography exam to have the outcomes. Read more about this study

Who is it for?: Ages 20 to 65 years
Conditions the study is for: Obstructive Sleep Apnea, Obesity
What is being tested?: mandibular advancement device
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: No sites listed yet
Study dates: 12 May 2016to 12 Jun 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 20 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

BMI ≥40 kg/m² and ≤ 49,9 kg/m²
Female and male patients (Both of gender patients) with ages between 20 to 65 years old
Obstructive Sleep Apnea (OSA) diagnosis by polysomnography

Who cannot join

sedative drugs users
Oxygen-dependent or decompensated lung disease
Decompensated congestive heart failure
Signs and symptoms of other sleeping disorders (narcolepsy, restless legs syndrome, insomnia)
craniofacial deformities carriers
previous OSAS Diagnosis and treatment

Show all 9Show fewer

Active Oncological diseases in the last ten years
Patients with less than 8 teeth per arcade;
Patients with advanced periodontitis;

About this study

Official title: Efficiency of Intraoral Appliance in the Treatment of Obstructive Sleep Apnea Syndrome in Obese Class III

Conditions: Obstructive Sleep Apnea, Obesity
Being tested: mandibular advancement device
Medical subject headings: Sleep Apnea, Obstructive, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

mandibular advancement deviceDevice

Study groups in NCT03517150
Study group	Role	What they receive
Experimental group	Experimental	This group will use an oral appliance for treatment of obstructive sleep apnea. The oral appliance is custom-made and its titration is attained by means of progressive mandibular advancement that incrementally moves the mandible forward. This group of patients will use the oral appliance for 45 days. Receives: Device: mandibular advancement device
Control group	Active comparator	This group will use a single adjustable silicone appliance in maxillar for 45 days, in order to compare to the experimental group. Receives: Device: mandibular advancement device

What is being measured

The primary outcome is the main question the study is designed to answer.

Quality of life
The Short-Form 36-Item Health Survey (SF-36) will be used to measure quality of life. This instrument will evaluate the physical health component (PHC) and the mental health component (MHC) through the following dimensions: functional capacity, physical aspects, pain, general health status, vitality, social aspects, emotional aspects and mental health.
Measured: 10 minutes
Daytime sleepiness
The Epworth sleepiness scale (ESS) wil measure the subjective daytime sleepiness, assesses the propensity to sleep under inappropriate circumstances. The ESS questionnaire consists of 8 questions about daytime sleepiness in various situations.
Measured: 5 minutes
Quality of sleep
The Pittsburgh Sleep Quality Index is the instrument deployed to evaluate the subjective quality of sleep and the presence of possible disorders. The overall score is formed by the sum of seven components, which can be considered individually, being: 1 - Subjective sleep quality; 2 - sleep latency; 3 - Sleep duration; 4 - Usual efficiency; 5 - Sleep disorders; 6 - Use of sleep medications; 7 - Daytime sleepiness and disturbances during the day. The overall score is formed by the sum of seven components, which can be considered individually, being: 1 - Subjective sleep quality; 2 - sleep latency; 3 - Sleep duration; 4 - Usual efficiency; 5 - Sleep disorders; 6 - Use of sleep medications; 7 - Daytime sleepiness and disturbances during the day. The score is determined by the sum of the seven components, with each answer being given a score between 0 and 3 points. The maximum score of the instrument is 21. The scores> 5 points indicate poor quality in the sleep pattern.
Measured: 5 minutes

Secondary outcomes (1)

Apnea-hypopnea index (AHI)
The obstructive Apnea-hypopnea Index is defined as the mean number of obstructive apneas and hypopneas per hour of sleep, thus: the occurrence of 5 to 14 events per hour of sleep means presence of mild apnea, 15 to 29 moderate apnea and ≥ 30 severe apnea. The AHI is derived from overnight polysomnography.
Measured: 8 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 May 201612 Jun 2018

First posted7 May 2018
Study start12 May 2016
Primary completion19 May 2018 (estimated)
Study completion12 Jun 2018 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (40)Papers the sponsor has linked to this study.
Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
More trials run by University of Sao PauloThe sponsor's other registered studies.
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: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03517150
Sponsor's protocol ID: FOB apnea
Status last verified: May 2018
First submitted: 24 Apr 2018
Last updated: 21 May 2018
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Takama N, Kurabayashi M. Influence of untreated sleep-disordered breathing on the long-term prognosis of patients with cardiovascular disease. Am J Cardiol. 2009 Mar 1;103(5):730-4. doi: 10.1016/j.amjcard.2008.10.035. Epub 2009 Jan 12.
PubMed 19231343
Flegal KM, Kit BK, Orpana H, Graubard BI. Association of all-cause mortality with overweight and obesity using standard body mass index categories: a systematic review and meta-analysis. JAMA. 2013 Jan 2;309(1):71-82. doi: 10.1001/jama.2012.113905.
PubMed 23280227
Hamilton GS, Meredith IT, Walker AM, Solin P. Obstructive sleep apnea leads to transient uncoupling of coronary blood flow and myocardial work in humans. Sleep. 2009 Feb;32(2):263-70. doi: 10.1093/sleep/32.2.263.
PubMed 19238814
Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014 Feb 26;311(8):806-14. doi: 10.1001/jama.2014.732.
PubMed 24570244
Prospective Studies Collaboration; Whitlock G, Lewington S, Sherliker P, Clarke R, Emberson J, Halsey J, Qizilbash N, Collins R, Peto R. Body-mass index and cause-specific mortality in 900 000 adults: collaborative analyses of 57 prospective studies. Lancet. 2009 Mar 28;373(9669):1083-96. doi: 10.1016/S0140-6736(09)60318-4. Epub 2009 Mar 18.
PubMed 19299006
Tefft BC. Prevalence of motor vehicle crashes involving drowsy drivers, United States, 1999-2008. Accid Anal Prev. 2012 Mar;45:180-6. doi: 10.1016/j.aap.2011.05.028.
PubMed 22269499
Gottlieb DJ, Ellenbogen JM, Bianchi MT, Czeisler CA. Sleep deficiency and motor vehicle crash risk in the general population: a prospective cohort study. BMC Med. 2018 Mar 20;16(1):44. doi: 10.1186/s12916-018-1025-7.
PubMed 29554902
Jurado-Gamez B, Guglielmi O, Gude F, Buela-Casal G. Workplace accidents, absenteeism and productivity in patients with sleep apnea. Arch Bronconeumol. 2015 May;51(5):213-8. doi: 10.1016/j.arbres.2014.07.003. Epub 2014 Aug 13. English, Spanish.
PubMed 25129165
Guglielmi O, Jurado-Gamez B, Gude F, Buela-Casal G. Occupational health of patients with obstructive sleep apnea syndrome: a systematic review. Sleep Breath. 2015 Mar;19(1):35-44. doi: 10.1007/s11325-014-1015-8. Epub 2014 Jun 22.
PubMed 24952614
Watson NF, Badr MS, Belenky G, Bliwise DL, Buxton OM, Buysse D, Dinges DF, Gangwisch J, Grandner MA, Kushida C, Malhotra RK, Martin JL, Patel SR, Quan SF, Tasali E. Recommended Amount of Sleep for a Healthy Adult: A Joint Consensus Statement of the American Academy of Sleep Medicine and Sleep Research Society. Sleep. 2015 Jun 1;38(6):843-4. doi: 10.5665/sleep.4716.
PubMed 26039963
Guglielmi O, Sanchez AI, Jurado-Gamez B, Buela-Casal G, Bardwell WA. [Obesity and sleep quality: the predictors of depression and anxiety in obstructive sleep apnea syndrome patients]. Rev Neurol. 2011 May 1;52(9):515-21. Spanish.
PubMed 21484722
Kern PA, Di Gregorio GB, Lu T, Rassouli N, Ranganathan G. Adiponectin expression from human adipose tissue: relation to obesity, insulin resistance, and tumor necrosis factor-alpha expression. Diabetes. 2003 Jul;52(7):1779-85. doi: 10.2337/diabetes.52.7.1779.
PubMed 12829646
Lee B, Shao J. Adiponectin and energy homeostasis. Rev Endocr Metab Disord. 2014 Jun;15(2):149-56. doi: 10.1007/s11154-013-9283-3.
PubMed 24170312
Ohashi K, Ouchi N, Matsuzawa Y. Anti-inflammatory and anti-atherogenic properties of adiponectin. Biochimie. 2012 Oct;94(10):2137-42. doi: 10.1016/j.biochi.2012.06.008. Epub 2012 Jun 17.
PubMed 22713764
Destors M, Tamisier R, Galerneau LM, Levy P, Pepin JL. [Pathophysiology of obstructive sleep apnea syndrome and its cardiometabolic consequences]. Presse Med. 2017 Apr;46(4):395-403. doi: 10.1016/j.lpm.2016.09.008. Epub 2017 Jan 23. French.
PubMed 28126503

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea

All Obstructive Sleep Apnea trials

Study at a glance

From the registry record, last updated by the sponsor on 21 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficiency of Intraoral Appliance in the Treatment of Obstructive Sleep Apnea Syndrome in Obese Class III
ClinicalTrials.gov ID: NCT03517150
Acronym / sponsor ID: FOB apnea
Conditions: Obstructive Sleep Apnea, Obesity
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 60 participants (estimated)
Lead sponsor: University of Sao PauloUniversity, hospital or other
Study start: 12 May 2016 (actual)
Primary completion: 19 May 2018 (estimated)
Study completion: 12 Jun 2018 (estimated)
First posted: 7 May 2018 (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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Experimental group	Experimental	Device: mandibular advancement deviceThis group will use an oral appliance for treatment of obstructive sleep apnea. The oral appliance is custom-made and its titration is attained by means of progressive mandibular advancement that incrementally moves the mandible forward. This group of patients will use the oral appliance for 45 days.
Control group	Active comparator	Device: mandibular advancement deviceThis group will use a single adjustable silicone appliance in maxillar for 45 days, in order to compare to the experimental group.

Who may qualify

Ages: 20 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

BMI ≥40 kg/m² and ≤ 49,9 kg/m²
Female and male patients (Both of gender patients) with ages between 20 to 65 years old
Obstructive Sleep Apnea (OSA) diagnosis by polysomnography

Key exclusion criteria (9 listed)

sedative drugs users
Oxygen-dependent or decompensated lung disease
Decompensated congestive heart failure
Signs and symptoms of other sleeping disorders (narcolepsy, restless legs syndrome, insomnia)
craniofacial deformities carriers

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
mandibular advancement device	Device	Control group, Experimental group

Primary outcome

Quality of life
Time frame: 10 minutes
The Short-Form 36-Item Health Survey (SF-36) will be used to measure quality of life. This instrument will evaluate the physical health component (PHC) and the mental health component (MHC) through the following dimensions: functional capacity, physical aspects, pain, general health status, vitality, social aspects, emotional aspects and mental health.
Daytime sleepiness
Time frame: 5 minutes
The Epworth sleepiness scale (ESS) wil measure the subjective daytime sleepiness, assesses the propensity to sleep under inappropriate circumstances. The ESS questionnaire consists of 8 questions about daytime sleepiness in various situations.
Quality of sleep
Time frame: 5 minutes
The Pittsburgh Sleep Quality Index is the instrument deployed to evaluate the subjective quality of sleep and the presence of possible disorders. The overall score is formed by the sum of seven components, which can be considered individually, being: 1 - Subjective sleep quality; 2 - sleep latency; 3 - Sleep duration; 4 - Usual efficiency; 5 - Sleep disorders; 6 - Use of sleep medications; 7 - Daytime sleepiness and disturbances during the day. The overall score is formed by the sum of seven components, which can be considered individually, being: 1 - Subjective sleep quality; 2 - sleep latency; 3 - Sleep duration; 4 - Usual efficiency; 5 - Sleep disorders; 6 - Use of sleep medications; 7 - Daytime sleepiness and disturbances during the day. The score is determined by the sum of the seven components, with each answer being given a score between 0 and 3 points. The maximum score of the instrument is 21. The scores> 5 points indicate poor quality in the sleep pattern.

1 secondary outcome

Apnea-hypopnea index (AHI)
Time frame: 8 hours

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2018.
Background: PubMed 19231343Takama N, Kurabayashi M. Influence of untreated sleep-disordered breathing on the long-term prognosis of patients with cardiovascular disease. Am J Cardiol. 2009 Mar 1;103(5):730-4. doi: 10.1016/j.amjcard.2008.10.035. Epub 2009 Jan 12.
Background: PubMed 23280227Flegal KM, Kit BK, Orpana H, Graubard BI. Association of all-cause mortality with overweight and obesity using standard body mass index categories: a systematic review and meta-analysis. JAMA. 2013 Jan 2;309(1):71-82. doi: 10.1001/jama.2012.113905.
Background: PubMed 19238814Hamilton GS, Meredith IT, Walker AM, Solin P. Obstructive sleep apnea leads to transient uncoupling of coronary blood flow and myocardial work in humans. Sleep. 2009 Feb;32(2):263-70. doi: 10.1093/sleep/32.2.263.
Background: PubMed 24570244Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014 Feb 26;311(8):806-14. doi: 10.1001/jama.2014.732.
Background: PubMed 19299006Prospective Studies Collaboration; Whitlock G, Lewington S, Sherliker P, Clarke R, Emberson J, Halsey J, Qizilbash N, Collins R, Peto R. Body-mass index and cause-specific mortality in 900 000 adults: collaborative analyses of 57 prospective studies. Lancet. 2009 Mar 28;373(9669):1083-96. doi: 10.1016/S0140-6736(09)60318-4. Epub 2009 Mar 18.
Background: PubMed 22269499Tefft BC. Prevalence of motor vehicle crashes involving drowsy drivers, United States, 1999-2008. Accid Anal Prev. 2012 Mar;45:180-6. doi: 10.1016/j.aap.2011.05.028.
Background: PubMed 29554902Gottlieb DJ, Ellenbogen JM, Bianchi MT, Czeisler CA. Sleep deficiency and motor vehicle crash risk in the general population: a prospective cohort study. BMC Med. 2018 Mar 20;16(1):44. doi: 10.1186/s12916-018-1025-7.
Background: PubMed 25129165Jurado-Gamez B, Guglielmi O, Gude F, Buela-Casal G. Workplace accidents, absenteeism and productivity in patients with sleep apnea. Arch Bronconeumol. 2015 May;51(5):213-8. doi: 10.1016/j.arbres.2014.07.003. Epub 2014 Aug 13. English, Spanish.
Background: PubMed 24952614Guglielmi O, Jurado-Gamez B, Gude F, Buela-Casal G. Occupational health of patients with obstructive sleep apnea syndrome: a systematic review. Sleep Breath. 2015 Mar;19(1):35-44. doi: 10.1007/s11325-014-1015-8. Epub 2014 Jun 22.
Background: PubMed 26039963Watson NF, Badr MS, Belenky G, Bliwise DL, Buxton OM, Buysse D, Dinges DF, Gangwisch J, Grandner MA, Kushida C, Malhotra RK, Martin JL, Patel SR, Quan SF, Tasali E. Recommended Amount of Sleep for a Healthy Adult: A Joint Consensus Statement of the American Academy of Sleep Medicine and Sleep Research Society. Sleep. 2015 Jun 1;38(6):843-4. doi: 10.5665/sleep.4716.
Background: PubMed 21484722Guglielmi O, Sanchez AI, Jurado-Gamez B, Buela-Casal G, Bardwell WA. [Obesity and sleep quality: the predictors of depression and anxiety in obstructive sleep apnea syndrome patients]. Rev Neurol. 2011 May 1;52(9):515-21. Spanish.
Background: PubMed 12829646Kern PA, Di Gregorio GB, Lu T, Rassouli N, Ranganathan G. Adiponectin expression from human adipose tissue: relation to obesity, insulin resistance, and tumor necrosis factor-alpha expression. Diabetes. 2003 Jul;52(7):1779-85. doi: 10.2337/diabetes.52.7.1779.
American Academy of Sleep MedicineLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Obstructive Sleep Apnea

RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing mandibular advancement device in people with Obstructive Sleep Apnea and Obesity, run by University of Sao Paulo.

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 9 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 21 May 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

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?

Quality of life (time frame: 10 minutes). The study lists 3 primary outcomes in all. 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 NCT03517150, which also lists 40 linked publications.

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 21 May 2018.