Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT04905238 |
| Other study ID # |
AOS-AD |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 31, 2020 |
| Est. completion date |
May 25, 2024 |
Study information
| Verified date |
May 2021 |
| Source |
Fundació d'investigació Sanitària de les Illes Balears |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Clinical trial on the effect of continuous positive pressure (CPAP). Objectives: 1) To
compare biomarkers of Alzheimer's disease in plasma samples from patients with Obstructive
sleep apnea (OSA) and without OSA. 2) To determine if CPAP reduces biomarkers of Alzheimer's
disease in plasma samples.
Description:
Randomized, parallel group, non-blinded, controlled clinical trial compared with conventional
treatment.
A. Protocol and intervention Patients with an Apnea-Hypopnea index (AHI)>30 h-1 will be
assigned, using a 1:1 randomization table, to lifestyle recommendations treatment or to
lifestyle recommendations plus nasal CPAP, for a period of 4 months. CPAP pressure will be
titled with automatic using an AutoSet II device, ResMed.
B. Sample size For the estimation of the sample size, previous data were used (PLoS ONE
2019;14(9): e0221255). In this case, in order to compare the effect of CPAP it would be
necessary to randomize a total of 100 patients with OSA and 30 control subjects.
C. Ethical considerations
- Indication of CPAP treatment for the prevention of Alzheimer's disease is not yet
accepted.
- Those patients with an urgent study indication for the diagnosis and treatment of
respiratory sleep disorders (professional drivers, respiratory failure or risk
professions) will be excluded from the project. In the other cases, the delay in
healthcare for the performance of Polysomnography and CPAP titration exceeds the
duration of the study, therefore that patients assigned to the control arm (conventional
treatment) will not be exposed to a higher risk than the general population.
D. Methods.
. Polysomnography. It will be used as a screening test previous the randomization of the
included patients. The exploration and its interpretation will be carried out following the
recommendations of the American Academy of Sleep Medicine. Based on the results of this test,
only those patients with an AHI will continue in the study when AHI >30 h-1. In these
patients the determinations listed below will be carried out immediately before randomization
(visit 1), at 4 weeks (visit 2), 16 weeks (visit 4) of allocation to the corresponding
treatment group
- Clinical data: The medication used and other associated diseases already diagnosed will
be recorded.
- Vital signs: recording of blood pressure, by means of a conventional triple taking, and
heart rate.
- Anthropometric characteristics: age and weight in basal conditions, the perimeter of the
neck and waist / hip index will be measured. The lean mass index will be determined
using a Bodystat 1500 impedance system (Bodystat Ltd, United Kingdom).
- Questionnaires: Epworth Sleepiness Scale, generic health-related quality of life (SF-12
and EuroQoL) and daily physical activity (International Physical Activity Questionnaire
or iPAQ).
- Laboratory findings: blood count, coagulation, creatinine, serum sodium and potassium;
glycated hemoglobin (HbA1c) and blood glucose and insulin levels in fasting, from these
values will determine the resistance and sensitivity to insulin using the HOMA and
QUICKI indices; total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides;
and troponin I, homocysteine, NT-pro BNP and highly sensitive C-reactive protein.
- Blood venous samples. 20 mL of venous blood will be collected, storing the plasma
obtained at -80 ºC for subsequent determination of β amiloid biomarkers (Aβ40, Aβ42, tau
y tau 181 (P-tau 181).
- Night pulse oximetry. To assess the existence of residual nocturnal hypoxemia.
- In the patients assigned to the CPAP treatment arm, a count of the hours of use of the
CPAP will be carried out at each visit by directly reading the automatic counter of each
equipment.
Statistic analysis The data will be expressed as mean ± standard deviation, median
(interquartile range) or percentage, depending on their type and distribution. For comparison
between groups Student's t-test, the U-Mann-Whitney or the chi-square test will be used, as
appropriate. The relations between variables will be analyzed using Pearson's correlation and
multiple linear regression analysis. The effect of treatment will be evaluated using general
linear models and repeated measures analysis of variance, with multiple comparisons post-hoc
using the Bonferroni test. A multiple logistic regression model will be applied to determine
the related variables with a response to treatment. Values of p <0.05 will be considered
statistically significant. The statistical study will be performed with the SPSS program
version 22.0.
