ORal ApplianCes for sLeep Apnea of the Elderly
NCT02325089, Phase 4, Unknown, Hospital de Clinicas de Porto Alegre
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | ORal ApplianCes for sLeep Apnea of the Elderly | ClinicalTrials.gov |
| NCT number | NCT02325089 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Phases | Phase 4 | ClinicalTrials.gov |
| Enrollment | 500 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Hospital de Clinicas de Porto Alegre | ClinicalTrials.gov |
| Conditions | Obstructive Sleep Apnea, Hypertension, Cardiovascular Disease | ClinicalTrials.gov |
| Interventions | Mandibular advancement device, Placebo | ClinicalTrials.gov |
| First posted | 2014-12-24 | ClinicalTrials.gov |
| Last updated | 2016-03-03 | ClinicalTrials.gov |
Registered outcomes 12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Arterial Blood Pressure Monitoring (ABPM) | 12 months | 24-h, diurnal, and sleep systolic and diastolic blood pressure. Systolic and diastolic dipping. | ClinicalTrials.gov |
| Secondary | Composite measure of Metabolic Syndrome including Glucose, Cholesterol, Triglyceride, Blood pressure, and Waist circumference | 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. | ClinicalTrials.gov |
| Secondary | Composite measure of Physical Ability | 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 | ClinicalTrials.gov |
| Secondary | Composite measure of Pain | 12 months | The pain assessment will be conducted by the following methods: 1) Profile of Chronic Pain 2) Assessment of Pain Catastrophizing | ClinicalTrials.gov |
| Secondary | Quality of life measured by WHOQOL | 12 months | The patients will answer the WHOQOL-Old module with 24 questions and the WHOQOL-Brief with 26 questions | ClinicalTrials.gov |
| Secondary | Circadian rhythm | 12 months | Munich Chronotype Questionnaire | ClinicalTrials.gov |
| Secondary | Composite measure of Cognitive function | 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. | ClinicalTrials.gov |
| Secondary | Ophthalmological assessment | 12 months | Retinal and choroidal changes | ClinicalTrials.gov |
| Secondary | Heart rate variability | 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). | ClinicalTrials.gov |
| Secondary | Cost-utility analysis measured by QALY | 60 months | Quality adjusted years of life (QALY) obtained by the intervention will be calculated. | ClinicalTrials.gov |
| Secondary | Change from Baseline Arterial Blood Pressure Monitoring (ABPM) at three months | 3 months | 24-h, diurnal, and sleep systolic and diastolic blood pressure. Systolic and diastolic dipping. | ClinicalTrials.gov |
| Secondary | Change from Baseline Arterial Blood Pressure Monitoring (ABPM) at six months | 6 months | 24-h, diurnal, and sleep systolic and diastolic blood pressure. Systolic and diastolic dipping. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 7
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Digit Span Test | Secondary outcome | ConductCognition |
| Picture Naming Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)