NCT04905238

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 31, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 27, 2021

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2025

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2025

Completed
Last Updated

May 1, 2025

Status Verified

April 1, 2025

Enrollment Period

4.7 years

First QC Date

May 24, 2021

Last Update Submit

April 29, 2025

Conditions

Sleep Apnea, Obstructive

Keywords

sleep apnea obstructive

Outcome Measures

Primary Outcomes (2)

  • Change from baseline in β-amyloid 40 (Aβ-40 and/or Aβ42) concentration

    To compare the change in Aβ-40 and/or Aβ42 levels between the patients allocated to CPAP group and the control group

    4 months

  • β-amyloid 40 (Aβ-40 and and/or Aβ42) concentration in OSA and in non-OSA patients

    To compare Aβ-40 and/or Aβ42 levels between OSA and non-OSA patients

    Baseline

Secondary Outcomes (13)

  • Phospho-Tau (P-Tau) concentration in OSA and in non-OSA patients

    Baseline

  • Apolipoprotein E (APOE) concentration in OSA and in non-OSA patients

    Baseline

  • Neurofilament light chain (NfL) concentration in OSA and in non-OSA patients

    Baseline

  • Microbiota population diversity from stool and nasopharyngeal samples in OSA and in non-OSA patients

    Baseline

  • Microbiota population abundance from stool and nasopharyngeal samples in OSA and in non-OSA patients

    Baseline

  • +8 more secondary outcomes

Study Arms (2)

Continuous positive airway pressure

ACTIVE COMPARATOR

Diet and general life style recommendations plus continuous positive airway pressure (CPAP).

Device: Continuous positive airway pressure

Conservative treatment

NO INTERVENTION

Diet and general life style recommendations.

Interventions

Continuous positive airway pressureDEVICE

Continuous positive airway pressure

Continuous positive airway pressure

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cases: patients with AHI \> 30/h
  • Controls: subjects with AHI \< 5/h and Epworth \<10

You may not qualify if:

  • Epworth\>18
  • BMI\<40Kg/M2
  • Arterial Hypertension
  • Diabetes Mellitus
  • Cerebrovascular disease
  • Ischemic heart disease
  • Cardiac arrhythmia
  • Chronic cardiovascular diseases
  • Daytime Oxygen saturation\>95%
  • Risk professions (professional drivers)
  • Concomitant treatment with antihypertensives, statins, antidiabetics, beta- blockers or systemic corticosteroids.
  • Pretreatment with CPAP.
  • Participation in another clinical trial thirty days prior to randomization
  • Abnormal values of a cognitive test.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Son Espases

Palma, Balearic Islands, 07006, Spain

Location

Hospital Son Llatzer

Palma, Balearic Islands, 07006, Spain

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 24, 2021

First Posted

May 27, 2021

Study Start

July 31, 2020

Primary Completion

April 10, 2025

Study Completion

May 6, 2025

Last Updated

May 1, 2025

Record last verified: 2025-04

Locations

ES(2)