Upper Airway Resistance SyndromeNCT02636621
Efficacy of Oral Appliance for Upper Airway Resistance Syndrome
A study testing Brazilian Dental Appliance in people with Upper Airway Resistance Syndrome, run by Associação Fundo de Incentivo à Pesquisa at 1 site in Brazil.
Trial summary
Introduction: The Upper Airway Resistance Syndrome (UARS) is a sleep disorder characterized by airway resistance to breathing during sleep that leads to arousals and daytime sleepiness. There are few studies about UARS treatment and there is not any gold standard treatment for it yet. Read more about this study
- Who is it for?
- Ages 25 to 50 years
- Conditions the study is for
- Upper Airway Resistance Syndrome
- What is being tested?
- Brazilian Dental Appliance
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2013to Oct 2017
- 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 25 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both genders
- Body mass index (BMI) ≤ 30Kg/m2
- Age from 25 to 50 years
- Clinical and polysomnographic diagnosis of Upper Airway Resistance Syndrome: Apnea/Hypopnea Index (AIH) ≤ 5 events/hour and Respiratory Disturbance Index (RDI) > 5 events/hour or > 30% of total sleep time with inspiratory flow limitation with excessive daytime somnolence or fatigue
Who cannot join
- Unsatisfactory dental condition or severe temporomandibular disfunction;
- Nasal obstruction;
- Alcohol abuse and excessive consumption of psychotropic drugs;
- Clinical, neurological or psychiatric diseases not treated
- Less than 6 hours of sleep
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Associação Fundo de Incentivo à Pesquisa (AFIP)
São Paulo, São Paulo, 04024-002
Sonia Togeiro, MD, PhD, sonia.togeiro@sono.org.br
Luciana Godoy, lu_bmg@yahoo.com.br
About this study
Official title: Efficacy of Oral Appliance for Upper Airway Resistance Syndrome: Randomized, Parallel, Placebo, Controlled Study
Introduction: The Upper Airway Resistance Syndrome (UARS) is a sleep disorder characterized by airway resistance to breathing during sleep that leads to arousals and daytime sleepiness. There are few studies about UARS treatment and there is not any gold standard treatment for it yet.
Objective: Primary: To evaluate the efficacy of oral appliance on improving fatigue in patients with UARS. Secondary: Evaluate the effects of treatment with oral appliance (OA) in patients with UARS on sleepiness, mood, cognition, quality of life, metabolism and autonomic nervous system.
Methods: Subjects with UARS (Apnea/Hypopnea Index - AHI - ≤ 5 events per hour of sleep and Respiratory Disturbance Index - RDI - > 5 events per hour or more than 30% of total sleep time with inspiratory flow limitation and with excessive daytime somnolence and/or fatigue) of both genders, with body mass index (BMI) lower than 30Kg/m2 and between 25 to 50 years of age will be included. Subjects will be randomly distributed in OA group and placebo (without treatment). At baseline evaluation, 6 months and 1 year after subjects will be submitted to sleep questionnaires, physical exam, otolaryngological evaluation, baseline polysomnography, Epworth sleepiness scale, Multiple Sleep Latency Test, fatigue scale, neurocognitive testing, autonomic nervous system analysis (heart rate variability) and metabolic evaluation. Mean and standard deviation will be used for descriptive statistical analysis if normal distribution, and median and percentiles (25%, 75%) for variables not normally distributed. To compare treatment groups T test (parametric) and Mann Whitney (non parametric) will be used. For adjusted analysis, linear regression analysis will be used.
- Conditions
- Upper Airway Resistance Syndrome
- Being tested
- Brazilian Dental Appliance, Placebo
- Keywords
- Fatigue, excessive daytime sleepiness, flow limitation
- Medical subject headings
- Fatigue, Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brazilian Dental ApplianceDevice
Also called Mandibular advancement device
Brazilian Dental Appliance is an oral appliance worn only during sleep that supports the jaw in a forward position to help maintain an open upper airway.
PlaceboOther
Also called Protective dental plate
The placebo consists in a protective dental plate worn only during sleep that do not interfere in the size of the upper airway.
| Study group | Role | What they receive |
|---|---|---|
| Brazilian Dental Appliance | Active comparator | The device increases the volume of the airway by mandibular traction. Receives: Device: Brazilian Dental Appliance |
| Placebo | Placebo comparator | Oral device that does not change the volume of the airway Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
Modified fatigue impact scale for Portuguese (MFIS- BR)
Measured: From the baseline evaluation to one year after the treatment with oral appliance
Secondary outcomes (15)
Subjective excessive daytime sleepiness
Epworth sleepiness scale
Measured: From the baseline evaluation to one year after the treatment with oral appliance
Objective excessive daytime sleepiness
Multiple Sleep Latency Test
Measured: From the baseline evaluation to one year after the treatment with oral appliance
Mood - Anxiety
Beck inventories (BAI)
Measured: From the baseline evaluation to one year after the treatment with oral appliance
Mood - Depression
Beck inventories (BDI)
Measured: From the baseline evaluation to one year after the treatment with oral appliance
Sustained attention
Psychomotor Vigilance Test (PVT)
Measured: From the baseline evaluation to one year after the treatment with oral appliance
Cognition - Memory
Digit Symbol Substitution Test (DSST)
Measured: From the baseline evaluation to one year after the treatment with oral appliance
Cognition - Learning strategies
Rey Auditory-Verbal Learning Test (RAVLT)
Measured: From the baseline evaluation to one year after the treatment with oral appliance
Cognition - Immediate and late memories
Wechsler Memory Scale (WMS)
Measured: From the baseline evaluation to one year after the treatment with oral appliance
Cognition - Processing speed ability
Stroop Color Test
Measured: From the baseline evaluation to one year after the treatment with oral appliance
Cognition - Visual attention
Trail Making Test - TMT
Measured: From the baseline evaluation to one year after the treatment with oral appliance
Quality of sleep
Pittsburgh Sleep Quality Index (PSQI)
Measured: From the baseline evaluation to one year after the treatment with oral appliance
Quality of life
Functional Outcomes of Sleep Questionnaire (FOSQ)
Measured: From the baseline evaluation to one year after the treatment with oral appliance
Stress
Teste de Lipp
Measured: From the baseline evaluation to one year after the treatment with oral appliance
Metabolism
Blood analysis of metabolism
Measured: From the baseline evaluation to one year after the treatment with oral appliance
Autonomic nervous system analysis
Heart rate variability
Measured: From the baseline evaluation to one year after the treatment with oral appliance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study startOct 2013
- Primary completionOct 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Upper Airway Resistance SyndromeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Associação Fundo de Incentivo à Pesquisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sonia Maria Guimaraes Pereira Togeiro Moura, Associação Fundo de Incentivo à Pesquisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02636621
- Sponsor's protocol ID
- SR94036
- Status last verified
- Jul 2016
- First submitted
- 16 Dec 2015
- Last updated
- 15 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
de Godoy LBM, Sousa KMM, Palombini LO, Poyares D, Dal-Fabbro C, Guimaraes TM, Tufik S, Togeiro SM. Long term oral appliance therapy decreases stress symptoms in patients with upper airway resistance syndrome. J Clin Sleep Med. 2020 Nov 15;16(11):1857-1862. doi: 10.5664/jcsm.8698.
PubMed 32686643Godoy LBM, Palombini L, Poyares D, Dal-Fabbro C, Guimaraes TM, Klichouvicz PC, Tufik S, Togeiro SM. Long-Term Oral Appliance Therapy Improves Daytime Function and Mood in Upper Airway Resistance Syndrome Patients. Sleep. 2017 Dec 1;40(12). doi: 10.1093/sleep/zsx175.
PubMed 29045745
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Oral Appliance for Upper Airway Resistance Syndrome: Randomized, Parallel, Placebo, Controlled Study
- ClinicalTrials.gov ID
- NCT02636621
- Acronym / sponsor ID
- SR94036
- Conditions
- Upper Airway Resistance Syndrome
- Keywords
- Fatigue, excessive daytime sleepiness, flow limitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Associação Fundo de Incentivo à PesquisaUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 22 Dec 2015 (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.
Introduction: The Upper Airway Resistance Syndrome (UARS) is a sleep disorder characterized by airway resistance to breathing during sleep that leads to arousals and daytime sleepiness. There are few studies about UARS treatment and there is not any gold standard treatment for it yet.
Objective: Primary: To evaluate the efficacy of oral appliance on improving fatigue in patients with UARS. Secondary: Evaluate the effects of treatment with oral appliance (OA) in patients with UARS on sleepiness, mood, cognition, quality of life, metabolism and autonomic nervous system.
Methods: Subjects with UARS (Apnea/Hypopnea Index - AHI - ≤ 5 events per hour of sleep and Respiratory Disturbance Index - RDI - > 5 events per hour or more than 30% of total sleep time with inspiratory flow limitation and with excessive daytime somnolence and/or fatigue) of both genders, with body mass index (BMI) lower than 30Kg/m2 and between 25 to 50 years of age will be included. Subjects will be randomly distributed in OA group and placebo (without treatment). At baseline evaluation, 6 months and 1 year after subjects will be submitted to sleep questionnaires, physical exam, otolaryngological evaluation, baseline polysomnography, Epworth sleepiness scale, Multiple Sleep Latency Test, fatigue scale, neurocognitive testing, autonomic nervous system analysis (heart rate variability) and metabolic evaluation. Mean and standard deviation will be used for descriptive statistical analysis if normal distribution, and median and percentiles (25%, 75%) for variables not normally distributed. To compare treatment groups T test (parametric) and Mann Whitney (non parametric) will be used. For adjusted analysis, linear regression analysis will be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brazilian Dental Appliance | Active comparator | Device: Brazilian Dental ApplianceThe device increases the volume of the airway by mandibular traction. |
| Placebo | Placebo comparator | Other: PlaceboOral device that does not change the volume of the airway |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Both genders
- Body mass index (BMI) ≤ 30Kg/m2
- Age from 25 to 50 years
- Clinical and polysomnographic diagnosis of Upper Airway Resistance Syndrome: Apnea/Hypopnea Index (AIH) ≤ 5 events/hour and Respiratory Disturbance Index (RDI) > 5 events/hour or > 30% of total sleep time with inspiratory flow limitation with excessive daytime somnolence or fatigue
Key exclusion criteria (5 listed)
- Unsatisfactory dental condition or severe temporomandibular disfunction;
- Nasal obstruction;
- Alcohol abuse and excessive consumption of psychotropic drugs;
- Clinical, neurological or psychiatric diseases not treated
- Less than 6 hours of sleep
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 |
|---|---|---|
| Brazilian Dental ApplianceAlso: Mandibular advancement deviceBrazilian Dental Appliance is an oral appliance worn only during sleep that supports the jaw in a forward position to help maintain an open upper airway. | Device | Brazilian Dental Appliance |
| PlaceboAlso: Protective dental plateThe placebo consists in a protective dental plate worn only during sleep that do not interfere in the size of the upper airway. | Other | Placebo |
Primary outcome
Fatigue
Time frame: From the baseline evaluation to one year after the treatment with oral appliance
Modified fatigue impact scale for Portuguese (MFIS- BR)
15 secondary outcomes
Subjective excessive daytime sleepiness
Time frame: From the baseline evaluation to one year after the treatment with oral appliance
Objective excessive daytime sleepiness
Time frame: From the baseline evaluation to one year after the treatment with oral appliance
Mood - Anxiety
Time frame: From the baseline evaluation to one year after the treatment with oral appliance
Mood - Depression
Time frame: From the baseline evaluation to one year after the treatment with oral appliance
Sustained attention
Time frame: From the baseline evaluation to one year after the treatment with oral appliance
Cognition - Memory
Time frame: From the baseline evaluation to one year after the treatment with oral appliance
Cognition - Learning strategies
Time frame: From the baseline evaluation to one year after the treatment with oral appliance
Cognition - Immediate and late memories
Time frame: From the baseline evaluation to one year after the treatment with oral appliance
Cognition - Processing speed ability
Time frame: From the baseline evaluation to one year after the treatment with oral appliance
Cognition - Visual attention
Time frame: From the baseline evaluation to one year after the treatment with oral appliance
Quality of sleep
Time frame: From the baseline evaluation to one year after the treatment with oral appliance
Quality of life
Time frame: From the baseline evaluation to one year after the treatment with oral appliance
Stress
Time frame: From the baseline evaluation to one year after the treatment with oral appliance
Metabolism
Time frame: From the baseline evaluation to one year after the treatment with oral appliance
Autonomic nervous system analysis
Time frame: From the baseline evaluation to one year after the treatment with oral appliance
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2016.
- Derived from this study: PubMed 32686643de Godoy LBM, Sousa KMM, Palombini LO, Poyares D, Dal-Fabbro C, Guimaraes TM, Tufik S, Togeiro SM. Long term oral appliance therapy decreases stress symptoms in patients with upper airway resistance syndrome. J Clin Sleep Med. 2020 Nov 15;16(11):1857-1862. doi: 10.5664/jcsm.8698.
- Derived from this study: PubMed 29045745Godoy LBM, Palombini L, Poyares D, Dal-Fabbro C, Guimaraes TM, Klichouvicz PC, Tufik S, Togeiro SM. Long-Term Oral Appliance Therapy Improves Daytime Function and Mood in Upper Airway Resistance Syndrome Patients. Sleep. 2017 Dec 1;40(12). doi: 10.1093/sleep/zsx175.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brazilian Dental Appliance in people with Upper Airway Resistance Syndrome, run by Associação Fundo de Incentivo à Pesquisa 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 4 inclusion and 5 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 15 Jul 2016. 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. Some participants in this study may receive a placebo. 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 LUCIANA GODOY, MD (551121490155, lu_bmg@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue (time frame: From the baseline evaluation to one year after the treatment with oral appliance). 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 NCT02636621, which also lists 2 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 15 Jul 2016.