- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02325089
ORal ApplianCes for sLeep Apnea of the Elderly (ORACLE)
Effect of Treating Sleep Apnea With Oral Appliances in the Elderly: ORACLE Study
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
RS
-
Porto Alegre, RS, Brazil, 90035-903
- Recruiting
- Hospital de Clinicas de Porto Alegre
-
Contact:
- Cintia Z Fiori, MSc
- Phone Number: 555133598289
- Email: cintiazfiori@gmail.com
-
Sub-Investigator:
- Cintia Z Fiori, MSc
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, Brazil, 95700-000
- Recruiting
- Hospital de Clinicas de Porto Alegre
-
Contact:
- Denis Martinez, MD, PhD
- Phone Number: 555130222282
- Email: denis@ufrgs.br
-
Contact:
- Cintia Z Fiori
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mandibular advancement device
Mandibular advancement device titrated to reduce or eliminate snoring and sleep apnea
|
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.
Other Names:
|
Placebo Comparator: Placebo
Oral appliance identical to the mandibular advancement device without mandibular advancement
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Arterial Blood Pressure Monitoring (ABPM)
Time Frame: 12 months
|
24-h, diurnal, and sleep systolic and diastolic blood pressure.
Systolic and diastolic dipping.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Composite measure of Metabolic Syndrome including Glucose, Cholesterol, Triglyceride, Blood pressure, and Waist circumference
Time Frame: 12 months
|
The NCEP ATP III panel defined metabolic syndrome as the presence of three or more of the following risk determinants: 1) 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. |
12 months
|
Composite measure of Physical Ability
Time Frame: 12 months
|
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
|
12 months
|
Composite measure of Pain
Time Frame: 12 months
|
The pain assessment will be conducted by the following methods: 1) Profile of Chronic Pain 2) Assessment of Pain Catastrophizing
|
12 months
|
Quality of life measured by WHOQOL
Time Frame: 12 months
|
The patients will answer the WHOQOL-Old module with 24 questions and the WHOQOL-Brief with 26 questions
|
12 months
|
Circadian rhythm
Time Frame: 12 months
|
Munich Chronotype Questionnaire
|
12 months
|
Composite measure of Cognitive function
Time Frame: 12 months
|
1) 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.
|
12 months
|
Ophthalmological assessment
Time Frame: 12 months
|
Retinal and choroidal changes
|
12 months
|
Heart rate variability
Time Frame: 12 months
|
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).
|
12 months
|
Cost-utility analysis measured by QALY
Time Frame: 60 months
|
Quality adjusted years of life (QALY) obtained by the intervention will be calculated.
|
60 months
|
Change from Baseline Arterial Blood Pressure Monitoring (ABPM) at three months
Time Frame: 3 months
|
24-h, diurnal, and sleep systolic and diastolic blood pressure.
Systolic and diastolic dipping.
|
3 months
|
Change from Baseline Arterial Blood Pressure Monitoring (ABPM) at six months
Time Frame: 6 months
|
24-h, diurnal, and sleep systolic and diastolic blood pressure.
Systolic and diastolic dipping.
|
6 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Denis Martinez, MD, PhD, Federal University of Rio Grande do Sul
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 140069
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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