Mild Obstructive Sleep Apnea SyndromeOSASNCT01461486
Continuous Positive Airway Pressure and Oral Appliances Treatments in Mild Obstructive Sleep Apnea
A study testing Continuous Positive Airway Pressure (CPAP) and Oral Appliance (BRD) in people with Mild Obstructive Sleep Apnea Syndrome, run by Associação Fundo de Incentivo à Pesquisa at 1 site in Brazil.
Trial summary
Treatment response of mild obstructive sleep apnea (OSA) to continuous positive airway pressure (CPAP) therapy and oral appliance (OA) is still controversial. The aim of this study is to evaluate the effect of CPAP and OA treatment on: objective and subjective sleepiness, cognitive deficits, mood changes, quality of… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mild Obstructive Sleep Apnea Syndrome
- What is being tested?
- Continuous Positive Airway Pressure (CPAP) and Oral Appliance (BRD)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2011to Nov 2019
- 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
- Both genders;
- body mass index lower than 35Kg/m2;
- age between 18 and 65 years old;
- polysomnographic and clinical diagnosis of mild apnea (apnea-hypopnea index of 5 or more events per hour of sleep and less than 15 and minimum mandibular protrusion of 7mm.
Who cannot join
- Unsatisfactory dental conditions (active periodontal disease, extensive caries or insufficient teeth for appliance content);
- temporomandibular disorders (chronic joint or muscle disease); central apnea; claustrophobia and severe otorhinolaryngologic diseases (severe nasal septal deviation, marked hypertrophy of nasal turbinates, hypertrophy of tonsils and/or adenoids sharp);
- excessive use of alcohol and psychoactive drugs;
- clinical, neurological or psychiatric decompensated diseases;
- others sleep diseases and previous obstructive sleep apnea treatment.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Associação Fundo de Incentivo à Pesquisa
São Paulo, São Paulo, 04024-002
About this study
Official title: Effectiveness of Continuous Positive Airway Pressure and Oral Appliances in Mild Obstructive Sleep Apnea: a Randomized, Parallel, Single Blind and Controlled Study
Treatment response of mild obstructive sleep apnea (OSA) to continuous positive airway pressure (CPAP) therapy and oral appliance (OA) is still controversial. The aim of this study is to evaluate the effect of CPAP and OA treatment on: objective and subjective sleepiness, cognitive deficits, mood changes, quality of life, inflammatory profile and metabolic cardiovascular and hormonal alterations in mild OSA subjects. Subjects with mild OSA (apnea -hypopnea index of 5 or more events per hour of sleep and less than 15), both genders, body mass index lower than 35Kg/m2 and age between 18 to 65 years will be included. They also must have a minimum mandibular protrusion of 7mm. Subjects will be randomly distributed in three groups: group 1 with CPAP, group 2 with OA and group 3 will be the control. At baseline evaluation, six months, one year and three years, all subjects will be submitted to sleep questionnaires, physical examination, ear-nose and throat evaluation, baseline polysomnography (and with CPAP for groups 1), Epworth Sleepiness Scale, Karolinska Sleepiness Scale, Stanford Sleepiness Scale, Maintenance of Wakefulness Test, Chalder Fatigue Scale, Neurocognitive testing, Beck Inventories of anxiety and depression, Functional Outcomes of Sleep Questionnaire (FOSQ), WHOQOL-BREF quality of life questionnaire, Short Form-36 quality of life questionnaire, questionnaire for sexual dysfunction, blood analysis for inflammatory, metabolic and hormonal evaluation, assessment of heart rate variability, 24 hour blood pressure monitoring and endothelial dysfunction. Sleep hygiene care was offer to three groups. Analysis mean and standard deviation will be used for descriptive statistical and a general linear model will be applied for analysis within groups on different time.
- Conditions
- Mild Obstructive Sleep Apnea Syndrome
- Being tested
- Continuous Positive Airway Pressure (CPAP), Oral Appliance (BRD)
- Keywords
- Continuous positive airway pressure, Oral appliance, mild Obstructive Sleep Apnea Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Positive Airway Pressure (CPAP)Device
Also called Resmed (trademark). Autoset Vantage - fixed pressure.
The device is a flow generator used to open the airway during sleep.
Oral Appliance (BRD)Device
Also called Brazilian Dental Appliance (BRD).
The device increases the volume of the airway by mandibular traction.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Positive Airway Pressure | Active comparator | Intervention group Receives: Device: Continuous Positive Airway Pressure (CPAP) |
| Oral Appliance (BRD) | Active comparator | Intervention group Receives: Device: Oral Appliance (BRD) |
| Hygiene sleep care | No intervention | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Excessive Daytime Sleepiness
Measured: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.
Secondary outcomes (12)
Evaluations of fatigue.
Measured: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral
Evaluation of cognition.
Performance Vigilance Test (PVT)
Measured: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.
Evaluation of depression.
Beck Depression Inventory - BDI
Measured: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.
Evaluation of quality of life.
Measured: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral
Evaluation of inflammation.
Blood analysis for inflammatory.
Measured: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral
Evaluation of blood pressure.
Assessment of heart rate variability, 24 hour blood pressure monitoring and endothelial dysfunction.
Measured: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral
Evaluation of sexual dysfunction.
Measured: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral
Evaluation of anxiety
Beck Anxiety Inventory - BAI
Measured: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral
Evaluation of metabolism
Blood analysis for metabolism
Measured: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral
Evaluation of hormonal alterations.
Blood analysis for hormonal alterations.
Measured: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.
Evaluation of heart rate variability
Assessment of heart rate variability.
Measured: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.
Evaluation of endothelial disfunction.
Assessment of endothelial disfunction.
Measured: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionNov 2019
- Study completionNov 2019
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 Mild Obstructive Sleep Apnea 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
- Investigator
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Associação Fundo de Incentivo à Pesquisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Lia Azeredo-Bittencourt, Associação Fundo de Incentivo à Pesquisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01461486
- Sponsor's protocol ID
- 1300/11
- Acronym
- OSAS
- Status last verified
- Nov 2019
- First submitted
- 25 Oct 2011
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Guimaraes TM, Poyares D, Oliveira E Silva L, Luz G, Coelho G, Dal Fabbro C, Tufik S, Bittencourt L. The treatment of mild OSA with CPAP or mandibular advancement device and the effect on blood pressure and endothelial function after one year of treatment. J Clin Sleep Med. 2021 Feb 1;17(2):149-158. doi: 10.5664/jcsm.8822.
PubMed 32964829M Guimaraes T, Bittencourt L, P Luz G, O Silva L, Burke P, Coelho G, Milani A, Badke L, Togeiro S, Tufik S, Poyares D. Association between nondipping pattern and EndoPAT signal in patients with mild obstructive sleep apnea. Sleep Med. 2018 Nov;51:9-14. doi: 10.1016/j.sleep.2018.05.041. Epub 2018 Jun 27.
PubMed 30077018
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Continuous Positive Airway Pressure and Oral Appliances in Mild Obstructive Sleep Apnea: a Randomized, Parallel, Single Blind and Controlled Study
- ClinicalTrials.gov ID
- NCT01461486
- Acronym / sponsor ID
- OSAS / 1300/11
- Conditions
- Mild Obstructive Sleep Apnea Syndrome
- Keywords
- Continuous positive airway pressure, Oral appliance, mild Obstructive Sleep Apnea Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Associação Fundo de Incentivo à PesquisaUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Nov 2019 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 28 Oct 2011 (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.
Treatment response of mild obstructive sleep apnea (OSA) to continuous positive airway pressure (CPAP) therapy and oral appliance (OA) is still controversial. The aim of this study is to evaluate the effect of CPAP and OA treatment on: objective and subjective sleepiness, cognitive deficits, mood changes, quality of life, inflammatory profile and metabolic cardiovascular and hormonal alterations in mild OSA subjects. Subjects with mild OSA (apnea -hypopnea index of 5 or more events per hour of sleep and less than 15), both genders, body mass index lower than 35Kg/m2 and age between 18 to 65 years will be included. They also must have a minimum mandibular protrusion of 7mm. Subjects will be randomly distributed in three groups: group 1 with CPAP, group 2 with OA and group 3 will be the control. At baseline evaluation, six months, one year and three years, all subjects will be submitted to sleep questionnaires, physical examination, ear-nose and throat evaluation, baseline polysomnography (and with CPAP for groups 1), Epworth Sleepiness Scale, Karolinska Sleepiness Scale, Stanford Sleepiness Scale, Maintenance of Wakefulness Test, Chalder Fatigue Scale, Neurocognitive testing, Beck Inventories of anxiety and depression, Functional Outcomes of Sleep Questionnaire (FOSQ), WHOQOL-BREF quality of life questionnaire, Short Form-36 quality of life questionnaire, questionnaire for sexual dysfunction, blood analysis for inflammatory, metabolic and hormonal evaluation, assessment of heart rate variability, 24 hour blood pressure monitoring and endothelial dysfunction. Sleep hygiene care was offer to three groups. Analysis mean and standard deviation will be used for descriptive statistical and a general linear model will be applied for analysis within groups on different time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Continuous Positive Airway Pressure | Active comparator | Device: Continuous Positive Airway Pressure (CPAP)Intervention group |
| Oral Appliance (BRD) | Active comparator | Device: Oral Appliance (BRD)Intervention group |
| Hygiene sleep care | No intervention | –Control group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Both genders;
- body mass index lower than 35Kg/m2;
- age between 18 and 65 years old;
- polysomnographic and clinical diagnosis of mild apnea (apnea-hypopnea index of 5 or more events per hour of sleep and less than 15 and minimum mandibular protrusion of 7mm.
Key exclusion criteria (5 listed)
- Unsatisfactory dental conditions (active periodontal disease, extensive caries or insufficient teeth for appliance content);
- temporomandibular disorders (chronic joint or muscle disease); central apnea; claustrophobia and severe otorhinolaryngologic diseases (severe nasal septal deviation, marked hypertrophy of nasal turbinates, hypertrophy of tonsils and/or adenoids sharp);
- excessive use of alcohol and psychoactive drugs;
- clinical, neurological or psychiatric decompensated diseases;
- others sleep diseases and previous obstructive sleep apnea treatment.
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 |
|---|---|---|
| Continuous Positive Airway Pressure (CPAP)Also: Resmed (trademark). Autoset Vantage - fixed pressure.The device is a flow generator used to open the airway during sleep. | Device | Continuous Positive Airway Pressure |
| Oral Appliance (BRD)Also: Brazilian Dental Appliance (BRD).The device increases the volume of the airway by mandibular traction. | Device | Oral Appliance (BRD) |
Primary outcome
Excessive Daytime Sleepiness
Time frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.
12 secondary outcomes
Evaluations of fatigue.
Time frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral
Evaluation of cognition.
Time frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.
Evaluation of depression.
Time frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.
Evaluation of quality of life.
Time frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral
Evaluation of inflammation.
Time frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral
Evaluation of blood pressure.
Time frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral
Evaluation of sexual dysfunction.
Time frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral
Evaluation of anxiety
Time frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral
Evaluation of metabolism
Time frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral
Evaluation of hormonal alterations.
Time frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.
Evaluation of heart rate variability
Time frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.
Evaluation of endothelial disfunction.
Time frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.
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 13 Nov 2019.
- Derived from this study: PubMed 32964829Guimaraes TM, Poyares D, Oliveira E Silva L, Luz G, Coelho G, Dal Fabbro C, Tufik S, Bittencourt L. The treatment of mild OSA with CPAP or mandibular advancement device and the effect on blood pressure and endothelial function after one year of treatment. J Clin Sleep Med. 2021 Feb 1;17(2):149-158. doi: 10.5664/jcsm.8822.
- Derived from this study: PubMed 30077018M Guimaraes T, Bittencourt L, P Luz G, O Silva L, Burke P, Coelho G, Milani A, Badke L, Togeiro S, Tufik S, Poyares D. Association between nondipping pattern and EndoPAT signal in patients with mild obstructive sleep apnea. Sleep Med. 2018 Nov;51:9-14. doi: 10.1016/j.sleep.2018.05.041. Epub 2018 Jun 27.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Positive Airway Pressure (CPAP) and Oral Appliance (BRD) in people with Mild Obstructive Sleep Apnea 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: finished, as of the sponsor's last update on 13 Nov 2019. 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?
Excessive Daytime Sleepiness (time frame: From the baseline evaluation to three years after the treatment with continuous positive airway pressure and appliance oral.). 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 NCT01461486, 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 13 Nov 2019.