ORal ApplianCes for sLeep Apnea of the Elderly

Hypertension Clinical Trial

— ORACLE  

Official title:

Effect of Treating Sleep Apnea With Oral Appliances in the Elderly: ORACLE Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02325089
• Other study ID #: 140069
• Status: Recruiting
• Phase: Phase 4
• First received: October 28, 2014
• Last updated: March 1, 2016
• Start date: July 2014
• Est. completion date: December 2020

Study information

• Verified date: March 2016
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Cintia Z Fiori, MsC
• Phone: 555130222282
• Email: cintiazfiori[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2020
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Apnea
• Cardiovascular Disease
• Cardiovascular Diseases
• Hypertension
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Mandibular advancement device
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.
• Placebo
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.

Locations

Country	Name	City	State
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	RS
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande do Sul

Sponsors (3)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arterial Blood Pressure Monitoring (ABPM)	24-h, diurnal, and sleep systolic and diastolic blood pressure. Systolic and diastolic dipping.	12 months	No
Secondary	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: 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	No
Secondary	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	12 months	No
Secondary	Composite measure of Pain	The pain assessment will be conducted by the following methods: 1) Profile of Chronic Pain 2) Assessment of Pain Catastrophizing	12 months	No
Secondary	Quality of life measured by WHOQOL	The patients will answer the WHOQOL-Old module with 24 questions and the WHOQOL-Brief with 26 questions	12 months	No
Secondary	Circadian rhythm	Munich Chronotype Questionnaire	12 months	No
Secondary	Composite measure of Cognitive function	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	No
Secondary	Ophthalmological assessment	Retinal and choroidal changes	12 months	No
Secondary	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).	12 months	No
Secondary	Cost-utility analysis measured by QALY	Quality adjusted years of life (QALY) obtained by the intervention will be calculated.	60 months	No
Secondary	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.	3 months	No
Secondary	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.	6 months	No