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Improving 24-hour Blood Pressure in Obstructive Sleep Apnea

NCT04021550 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2023-05-19

No results posted yet for this study

Summary

This study examines the combined effects of an angiotensin receptor blocker (ARB), antioxidant supplementation, and continuous positive airway pressure (CPAP) therapy on the lowering of 24-hour blood pressure in persons with moderate to severe Obstructive Sleep Apnea (OSA). All participants will undergo CPAP therapy as prescribed by their doctor; however, half of the participants will receive the combined ARB and antioxidant treatment while the other half of the participants will receive a placebo.

Conditions

Interventions

DEVICE

Continuous Positive Airway Pressure CPAP

All subjects will be advised to use their continuous positive airway pressure (CPAP) in accordance to their physician's guidelines.

DRUG

Telmisartan 80mg

Subjects in this group will receive 80mg/day of Telmisartan (an angiotensin receptor blocker). Treatments will be administered in pre-packaged blister packages. Subjects will take Telmisartan once per day for 6 weeks.

DIETARY_SUPPLEMENT

Alpha-Lipoic Acid 600mg

Subjects in this group will receive 600mg/day of Alpha-Lipoic Acid (an antioxidant). Treatments will be administered in pre-packaged blister packages. Subjects will take Alpha-Lipoic Acid once per day for 6 weeks.

OTHER

Microcrystalline Cellulose

Subjects in this group will receive two capsules of Microcrystalline Cellulose (placebo). Treatments will be administered in pre-packaged blister packages. Subjects will take placebo pills once per day for 6 weeks.

Sponsors & Collaborators

  • Heart and Stroke Foundation of Canada

    collaborator OTHER

  • Michael Smith Foundation for Health Research

    collaborator OTHER

  • University of British Columbia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-31
Primary Completion
2026-12-31
Completion
2026-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04021550 on ClinicalTrials.gov