Obstructive Sleep ApneaPhase 4ORACLENCT02325089
ORal ApplianCes for sLeep Apnea of the Elderly
A Phase 4 study testing Mandibular advancement device in people with Obstructive Sleep Apnea and Hypertension, run by Hospital de Clinicas de Porto Alegre at 2 sites in Brazil.
Trial summary
Sleep apnea involves significant increases in disease and death, but its consequences in people over 65 years of age are incompletely recognized. Intraoral mandibular advancement appliances reduce the number of apneas and hypopneas. Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Obstructive Sleep Apnea, Hypertension, Cardiovascular Disease
- What is being tested?
- Mandibular advancement device
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 2 sitesBrazil
- Study dates
- Jul 2014to Dec 2020
- Phase
- Phase 4
- 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 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Mandibular advancement of at least 3 mm
- Mouth opening of at least 30 mm
- Sleep apnea with apnea-hypopnea index between 10 and 50 events/hour
- Agree to participate in the study by signing the informed consent
Who cannot join
- Already in treatment for sleep apnea
- Self-reported severe or terminal Illness
- Physical disability
- Inability to communicate verbally
- Dementia in the Mini-Mental State Examination
- Plan to move to a different a city or to be institutionalized in the next year
- Participation in another clinical trial
- Less than eight teeth, periodontal disease, or TMJ problems
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites, 2 recruiting
- Recruiting
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
Cintia Z Fiori, MSc, 555133598289, cintiazfiori@gmail.com
Cintia Z Fiori, MSc
- Recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 95700-000
Denis Martinez, MD, PhD, 555130222282, denis@ufrgs.br
Cintia Z Fiori
About this study
Official title: Effect of Treating Sleep Apnea With Oral Appliances in the Elderly: ORACLE Study
Sleep apnea involves significant increases in disease and death, but its consequences in people over 65 years of age are incompletely recognized. Intraoral mandibular advancement appliances reduce the number of apneas and hypopneas. The investigators hypothesized that oral appliances provided to the elderly may prevent hypertension and other consequences of sleep apnea in large populations, at a favorable cost/benefit relationship for the public health system.
Read the detailed description
Sleep disorders involve significant increases in morbidity and mortality, particularly in those over 60 years. Sleep apnea is the leading identifiable cause of hypertension, which is the main cause of cardiovascular disease. Some degree of sleep apnea is present in up to 95% of the elderly. Intraoral mandibular advancement appliances reduce the number of apneas and hypopneas.
We hypothesized that reducing the number of sleep apnea events through oral appliances is effective in preventing high blood pressure and other consequences of sleep apnea in the elderly in the public health system setting. In this superiority parallel, randomized, and double-blinded study we will compare the effect of an intraoral appliance with mandibular advancement to a placebo device without mandibular advancement in preventing high blood pressure and other consequences of sleep apnea in the elderly. The duration of intervention will be of 12 months, with assessments at three, six months, and 12 months.
- Being tested
- Mandibular advancement device, Placebo
- Keywords
- Elderly, Obstructive Sleep Apnea, Mandibular advancement oral appliance, Hypertension, Cardiovascular disease, Quality of life
- Medical subject headings
- Sleep Apnea, Obstructive, Hypertension, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandibular advancement deviceDevice
Also called MAD
Use of a mandibular advancement device every night during one year. Device will be titrated to reduce or - if possible - eliminate snoring and sleep apnea.
PlaceboDevice
Also called Placebo device
Placebo oral appliance will be identical to the mandibular advancement device without, however, the attachemnt to allow mandibular advancement. It will be used every night during one year.
| Study group | Role | What they receive |
|---|---|---|
| Mandibular advancement device | Experimental | Mandibular advancement device titrated to reduce or eliminate snoring and sleep apnea Receives: Device: Mandibular advancement device |
| Placebo | Placebo comparator | Oral appliance identical to the mandibular advancement device without mandibular advancement Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial Blood Pressure Monitoring (ABPM)
24-h, diurnal, and sleep systolic and diastolic blood pressure. Systolic and diastolic dipping.
Measured: 12 months
Secondary outcomes (11)
Composite measure of Metabolic Syndrome including Glucose, Cholesterol, Triglyceride, Blood pressure, and Waist circumference
The NCEP ATP III panel defined metabolic syndrome as the presence of three or more of the following risk determinants:
- triglyceride levels > to 150 mg / dl; 2) HDL-cholesterol < 40 for men and < 50 for women; 3) glucose > to 110 mg / dl; 4) blood pressure: Systolic > 130 mmHg and / or diastolic blood pressure > 85 mm Hg; 5) waist circumference > 88 cm in women and > 102 cm in men.
Measured: 12 months
Composite measure of Physical Ability
The following areas will be evaluated: 1) functional capacity (six-minute walk test), 2) balance (Berg balance scale: 14-item scale designed to measure balance of the older adult in a clinical setting.), 3) flexibility (Wells Sit and Reach Test), 4) mobility (timed up and go test), 5) Force-Velocity Characteristics of Upper and Lower Limbs (Handgrip strength testing: upper, and Sit-to-stand test: Lower), 6) Recall of falls in the last six months
Measured: 12 months
Composite measure of Pain
The pain assessment will be conducted by the following methods: 1) Profile of Chronic Pain 2) Assessment of Pain Catastrophizing
Measured: 12 months
Quality of life measured by WHOQOL
The patients will answer the WHOQOL-Old module with 24 questions and the WHOQOL-Brief with 26 questions
Measured: 12 months
Circadian rhythm
Munich Chronotype Questionnaire
Measured: 12 months
Composite measure of Cognitive function
- Mini Mental State Examination (MMSE); 2) Digit Span Test, 3) Verbal Fluency Test, 4) The Rey Auditory-Verbal Learning Test, 5) The Boston Naming Test, 6) Trail Making Test, 7) Stroop Color and Word Test, 8) Benton Visual Retention Test (is an assessment of visual perception, memory, and visuo-constructive abilities), 9) Beck Anxiety and Depression Inventory, 10) SYMPTOM CHECK LIST 90R- SCL90-R.
Measured: 12 months
Ophthalmological assessment
Retinal and choroidal changes
Measured: 12 months
Heart rate variability
Heart rate variability (HRV) The following HRV indices will be calculated in time and in frequency domains using 5-min segments as recommended by the European Society of Cardiology and North American Society of Pacing and Electrophysiology: the mean of all normal RR intervals (mean RR), the root mean square of successive differences of normal adjacent RR intervals (rMSSD), the low-frequency component (LF, 0.04 - 0.15 Hz) and the high-frequency component (HF, 0.15 - 0.5 Hz).
Measured: 12 months
Cost-utility analysis measured by QALY
Quality adjusted years of life (QALY) obtained by the intervention will be calculated.
Measured: 60 months
Change from Baseline Arterial Blood Pressure Monitoring (ABPM) at three months
24-h, diurnal, and sleep systolic and diastolic blood pressure. Systolic and diastolic dipping.
Measured: 3 months
Change from Baseline Arterial Blood Pressure Monitoring (ABPM) at six months
24-h, diurnal, and sleep systolic and diastolic blood pressure. Systolic and diastolic dipping.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2020 (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.
- More trials run by Hospital de Clinicas de Porto AlegreThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Denis Martinez, Hospital de Clinicas de Porto Alegre
- Investigators
- Denis Martinez, MD, PhD, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02325089
- Sponsor's protocol ID
- 140069
- Acronym
- ORACLE
- Status last verified
- Mar 2016
- First submitted
- 28 Oct 2014
- Last updated
- 3 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Treating Sleep Apnea With Oral Appliances in the Elderly: ORACLE Study
- ClinicalTrials.gov ID
- NCT02325089
- Acronym / sponsor ID
- ORACLE / 140069
- Keywords
- Elderly, Obstructive Sleep Apnea, Mandibular advancement oral appliance, Hypertension, Cardiovascular disease, Quality of life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Jul 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 24 Dec 2014 (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.
Sleep apnea involves significant increases in disease and death, but its consequences in people over 65 years of age are incompletely recognized. Intraoral mandibular advancement appliances reduce the number of apneas and hypopneas. The investigators hypothesized that oral appliances provided to the elderly may prevent hypertension and other consequences of sleep apnea in large populations, at a favorable cost/benefit relationship for the public health system.
Detailed description
Sleep disorders involve significant increases in morbidity and mortality, particularly in those over 60 years. Sleep apnea is the leading identifiable cause of hypertension, which is the main cause of cardiovascular disease. Some degree of sleep apnea is present in up to 95% of the elderly. Intraoral mandibular advancement appliances reduce the number of apneas and hypopneas.
We hypothesized that reducing the number of sleep apnea events through oral appliances is effective in preventing high blood pressure and other consequences of sleep apnea in the elderly in the public health system setting. In this superiority parallel, randomized, and double-blinded study we will compare the effect of an intraoral appliance with mandibular advancement to a placebo device without mandibular advancement in preventing high blood pressure and other consequences of sleep apnea in the elderly. The duration of intervention will be of 12 months, with assessments at three, six months, and 12 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mandibular advancement device | Experimental | Device: Mandibular advancement deviceMandibular advancement device titrated to reduce or eliminate snoring and sleep apnea |
| Placebo | Placebo comparator | Device: PlaceboOral appliance identical to the mandibular advancement device without mandibular advancement |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Mandibular advancement of at least 3 mm
- Mouth opening of at least 30 mm
- Sleep apnea with apnea-hypopnea index between 10 and 50 events/hour
- Agree to participate in the study by signing the informed consent
Key exclusion criteria (8 listed)
- Already in treatment for sleep apnea
- Self-reported severe or terminal Illness
- Physical disability
- Inability to communicate verbally
- Dementia in the Mini-Mental State Examination
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 deviceAlso: MADUse of a mandibular advancement device every night during one year. Device will be titrated to reduce or - if possible - eliminate snoring and sleep apnea. | Device | Mandibular advancement device |
| PlaceboAlso: Placebo devicePlacebo oral appliance will be identical to the mandibular advancement device without, however, the attachemnt to allow mandibular advancement. It will be used every night during one year. | Device | Placebo |
Primary outcome
Arterial Blood Pressure Monitoring (ABPM)
Time frame: 12 months
24-h, diurnal, and sleep systolic and diastolic blood pressure. Systolic and diastolic dipping.
11 secondary outcomes
Composite measure of Metabolic Syndrome including Glucose, Cholesterol, Triglyceride, Blood pressure, and Waist circumference
Time frame: 12 months
Composite measure of Physical Ability
Time frame: 12 months
Composite measure of Pain
Time frame: 12 months
Quality of life measured by WHOQOL
Time frame: 12 months
Circadian rhythm
Time frame: 12 months
Composite measure of Cognitive function
Time frame: 12 months
Ophthalmological assessment
Time frame: 12 months
Heart rate variability
Time frame: 12 months
Cost-utility analysis measured by QALY
Time frame: 60 months
Change from Baseline Arterial Blood Pressure Monitoring (ABPM) at three months
Time frame: 3 months
Change from Baseline Arterial Blood Pressure Monitoring (ABPM) at six months
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2016.
- Individual participant dataSharing planned: Undecided
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
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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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Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
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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.
Denis Martinez, MD, PhD principal investigator
Federal University of Rio Grande do Sul
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mandibular advancement device in people with Obstructive Sleep Apnea and Hypertension, run by Hospital de Clinicas de Porto Alegre at 2 sites 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 8 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 3 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Cintia Z Fiori, MsC (555130222282, cintiazfiori@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial Blood Pressure Monitoring (ABPM) (time frame: 12 months). 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 3 Mar 2016.