Obstructive Sleep ApneaNCT01336556
Titration of Continuous Positive Airway Pressure Could Predict Success of Oral Appliance to Treat Sleep Apnea
A study testing Oral appliance in people with Obstructive Sleep Apnea, run by Associacao Fundo de Incentivo a Psicofarmcologia at 1 site in Brazil.
Trial summary
Background: The oral appliances have been increasingly used in the treatment of primary snoring and in patients with mild obstructive sleep apnea syndrome besides being treatment options in adults with moderate to severe sleep apnea who did not accept or adapt to continuous positive airway pressure (CPAP). Read more about this study
- Who is it for?
- Ages 25 to 65 years, men only
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Oral appliance
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2010to Nov 2011
- 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 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male subjects aged between 25 and 65 years old
- Epworth sleepiness Scale > 9
- Apnea-hypopnea index between 5 and 30
Who cannot join
- Presence of clinical disease (chronic obstructive pulmonary disease, asthma) and other sleep disorders.
- Presence of anatomical obstructive upper airway, tonsil grade III e IV, septal deviation and grade III that may affect the outcome of CPAP
- Loss of posterior dental support to undermine the retention of oral appliance
- Active of periodontal disease, compared Dental crow/dental root less than or equal to 1 (c/r ≤ 1) need primary dental care (cavities, root canal treatment or retreatment, dentures, i.e. outlying), open bite
- Protrusive displacement lass then five millimeters
- Limited mouth opening
Show all 11Show fewer
- Alcoholism
- Use of sleep-inducing medications
- Habits or occupation that lead to sleep deprivation or alteration of the sleep-wake cycle
- Intolerance to CPAP
- Obesity grade II (moderate) or III (severe)
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Instituto do Sono/ Associação Fundo de Incentivo a Psicofarmacologia
São Paulo, São Paulo, 04023-062
Lia Rita A Bittencourt, MD,PhD, 115521490155, lia@psicobio.epm.br
Lia Rita A Bittencourt, MD, PhD, 115521490155, lia@psicobio.epm.br
About this study
Official title: Optimal Titration of Continuous Positive Airway Pressure Could Predict Success of Oral Appliance to Treat Obstructive Sleep Apnea Syndrome
Background: The oral appliances have been increasingly used in the treatment of primary snoring and in patients with mild obstructive sleep apnea syndrome besides being treatment options in adults with moderate to severe sleep apnea who did not accept or adapt to continuous positive airway pressure (CPAP). It is not well established yet in the literature, which patients with mild to moderate OSA will present a good response to treatment with oral appliances.
Objective: To determine a value of CPAP pressure that correlates with a favorable response to the use of oral appliance in patients with mild to moderate sleep apnea.
Patients and Methods: Two groups of 30 male patients (25-65 years, body mass index < 35 kg/m2) will be selected: the first group with an apnea-hypopnea index (AHI) between 5 and 15 events per hour of sleep and the second one with an AHI between 15 and 30 events per hour of sleep. Each patient will undergo three polysomnographic recordings (baseline, CPAP titration, after two months of treatment with oral appliance). Subjective (sleep disorders questionnaire, the Epworth Sleepiness Scale, and sleep diaries) and objective (polysomnography) parameters of sleep will be evaluated, besides the quality of life (SF-36), mood (POMS), and anthropometric measurements (neck circumference and craniofacial characteristic). Good response to treatment with the AIO will be considered as a 50% reduction in the baseline AHI index or AHI after treatment less than 5 events per hour of sleep.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Oral appliance
- Keywords
- Oral appliance, Continuous positive airway pressure, Obstructive Sleep Apnea Syndrome, Snore
- Medical subject headings
- Sleep Apnea, Obstructive, Snoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral applianceProcedure or surgery
Anterior mandibular repositioner: used for two months
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective sleep parameters
polysomnographic date of sleep stages percentages, sleep efficience, arousals, apnea-hypopnea index, oxyhemoglobin saturation
Measured: two months after the baseline recording
Secondary outcomes (2)
Subjective sleep parameters
Sleep disorders questionnaire, the Epworth Sleepiness Scale, and sleep diaries
Measured: two months after the baseline recording
Quality of life, mood, and anthropometric measurements
SF-36, POMS, neck circumference and craniofacial characteristic
Measured: two months after the baseline recording
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2011 (estimated)
- Study startOct 2010
- Primary completionNov 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Associacao Fundo de Incentivo a Psicofarmcologia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Lia Azeredo-Bittencourt, Associacao Fundo de Incentivo a Psicofarmcologia
- Investigators
- Lia Rita A Bittencourt, MD, PhD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01336556
- Sponsor's protocol ID
- 0352/09T
- Status last verified
- Oct 2011
- First submitted
- 14 Apr 2011
- Last updated
- 26 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Titration of Continuous Positive Airway Pressure Could Predict Success of Oral Appliance to Treat Obstructive Sleep Apnea Syndrome
- ClinicalTrials.gov ID
- NCT01336556
- Acronym / sponsor ID
- 0352/09T
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Oral appliance, Continuous positive airway pressure, Obstructive Sleep Apnea Syndrome, Snore
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Associacao Fundo de Incentivo a PsicofarmcologiaUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Nov 2011 (estimated)
- First posted
- 18 Apr 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.
Background: The oral appliances have been increasingly used in the treatment of primary snoring and in patients with mild obstructive sleep apnea syndrome besides being treatment options in adults with moderate to severe sleep apnea who did not accept or adapt to continuous positive airway pressure (CPAP). It is not well established yet in the literature, which patients with mild to moderate OSA will present a good response to treatment with oral appliances.
Objective: To determine a value of CPAP pressure that correlates with a favorable response to the use of oral appliance in patients with mild to moderate sleep apnea.
Patients and Methods: Two groups of 30 male patients (25-65 years, body mass index < 35 kg/m2) will be selected: the first group with an apnea-hypopnea index (AHI) between 5 and 15 events per hour of sleep and the second one with an AHI between 15 and 30 events per hour of sleep. Each patient will undergo three polysomnographic recordings (baseline, CPAP titration, after two months of treatment with oral appliance). Subjective (sleep disorders questionnaire, the Epworth Sleepiness Scale, and sleep diaries) and objective (polysomnography) parameters of sleep will be evaluated, besides the quality of life (SF-36), mood (POMS), and anthropometric measurements (neck circumference and craniofacial characteristic). Good response to treatment with the AIO will be considered as a 50% reduction in the baseline AHI index or AHI after treatment less than 5 events per hour of sleep.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male subjects aged between 25 and 65 years old
- Epworth sleepiness Scale > 9
- Apnea-hypopnea index between 5 and 30
Key exclusion criteria (11 listed)
- Presence of clinical disease (chronic obstructive pulmonary disease, asthma) and other sleep disorders.
- Presence of anatomical obstructive upper airway, tonsil grade III e IV, septal deviation and grade III that may affect the outcome of CPAP
- Loss of posterior dental support to undermine the retention of oral appliance
- Active of periodontal disease, compared Dental crow/dental root less than or equal to 1 (c/r ≤ 1) need primary dental care (cavities, root canal treatment or retreatment, dentures, i.e. outlying), open bite
- Protrusive displacement lass then five millimeters
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 |
|---|---|---|
| Oral applianceAnterior mandibular repositioner: used for two months | Procedure or surgery | – |
Primary outcome
Objective sleep parameters
Time frame: two months after the baseline recording
polysomnographic date of sleep stages percentages, sleep efficience, arousals, apnea-hypopnea index, oxyhemoglobin saturation
2 secondary outcomes
Subjective sleep parameters
Time frame: two months after the baseline recording
Quality of life, mood, and anthropometric measurements
Time frame: two months after the baseline recording
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2011.
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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.
Lia Rita A Bittencourt, MD, PhD principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral appliance in people with Obstructive Sleep Apnea, run by Associacao Fundo de Incentivo a Psicofarmcologia 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 11 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 Oct 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thays CA Cunha (551121490155, thayscrosara@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective sleep parameters (time frame: two months after the baseline recording). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2011.