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Obstructive Sleep ApneaEarly Phase 1NCT04021550

Improving 24-hour Blood Pressure in Obstructive Sleep Apnea

A Early Phase 1 study testing Continuous Positive Airway Pressure CPAP, Telmisartan 80mg and Alpha-Lipoic Acid 600mg in people with Obstructive Sleep Apnea, run by University of British Columbia.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Obstructive Sleep Apnea
What is being tested?
Continuous Positive Airway Pressure CPAP, Telmisartan 80mg and Alpha-Lipoic Acid 600mg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
May 2023to Dec 2026
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Apnea/Hypopnea Index (AHI) greater than/equal to 15 events per hour of sleep
  • No prior use of CPAP
  • Body mass index less than 30kg/m2
  • Does not take ARBs or angiotensin converting enzyme inhibitors for blood pressure control
  • Females of childbearing potential on an effective or highly effective means of contraception

Who cannot join

  • Prescribed and/or taking the following medications: diuretics (including potassium-sparing diuretics), Digoxin, lithium salts, and/or nonsteroidal anti-inflammatory drugs
  • Over the counter supplements that affect the cardiovascular system, such as fish oils, vitamins, or other antioxidants
  • History of heart failure
  • History of myocardial infarction
  • History of coronary artery disease
  • History of stroke
Show all 14Show fewer
  • History of diabetes mellitus
  • History of impaired renal function
  • History of chronic obstructive pulmonary disease
  • History of asthma
  • History of central sleep apnea
  • Smoked within the past year
  • Hypotensive (Systolic blood pressure (SBP) <90 mmHg and diastolic blood pressure (DBP) <60 mmHg)
  • Females who do not have a means of contraception, are pregnant, planning to become pregnant, and/or are breast-feeding

About this study

Official title: Combined Treatment of Angiotensin Receptor Blocker and Antioxidant Supplementation as a Novel Adjunctive Therapy for 24-hour Blood Pressure Improvement in Obstructive Sleep Apnea

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.

Read the detailed description

OSA is a sleep disorder characterized by repetitive collapses (apneas) or partial collapses (hypopneas) of the upper airway. These airway obstructions result in intermittent reductions in arterial oxygen saturation (hypoxia), which causes a reflexive increase in sympathetic activation and systemic vasoconstriction. Resumption of breathing results in transient surges in blood pressure (BP) that can reach as high as 240/130 mm/Hg.

OSA effects up to 24% of the adult population and evidence suggests a causal relationship between OSA and cardiovascular disease (CVD) development. While the exact mechanisms are unknown, data from animal and human models suggest that exposure to chronic intermittent hypoxia (IH) plays a significant role in the pathogenesis of cardiovascular comorbidity. Persons with OSA exhibit increased daytime sympathetic activity, markers of oxidative stress, and vasoactive hormones, particularly angiotensin II, that contribute to systemic vasoconstriction. These factors contribute to early endothelial dysfunction and contribute to sustained elevations in BP.

While CPAP is the gold standard OSA treatment, adherence rates are low and evidence suggests that treatment does not reduce the rates of CVD in large population-based studies.

Telmisartan is a receptor blocker for angiotensin II and not only has BP lowering effects, but also has unique anti-inflammatory properties and beneficial influences on endothelial function. The addition of an antioxidant supplement may increase the reactive oxygen species scavenging capacity and, in combination with ARB treatment, may provide more robust effects on BP in persons with OSA.

Being tested
Continuous Positive Airway Pressure CPAP, Telmisartan 80mg, Alpha-Lipoic Acid 600mg, Microcrystalline Cellulose
Keywords
Telmisartan, Alpha-Lipoic Acid, Continuous Positive Airway Pressure, 24-hour blood pressure
Medical subject headings
Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Continuous Positive Airway Pressure CPAPDevice

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

  • Telmisartan 80mgDrug

    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.

  • Alpha-Lipoic Acid 600mgDietary supplement

    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.

  • Microcrystalline CelluloseOther

    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.

Study groups in NCT04021550
Study groupRoleWhat they receive
Combined TreatmentExperimentalSubjects will be given 80 mg/day Telmisartan + 600 mg/day Alpha-Lipoic Acid. Subjects will also be prescribed CPAP therapy by their physician. Subjects will be instructed to use their CPAP device according to their physician's guidelines.
Receives: Device: Continuous Positive Airway Pressure CPAP; Drug: Telmisartan 80mg; Dietary Supplement: Alpha-Lipoic Acid 600mg
Placebo ControlPlacebo comparatorSubjects will be given placebo capsules. Subjects will also be prescribed CPAP therapy by their physician. Subjects will be instructed to use their CPAP device according to their physician's guidelines.
Receives: Device: Continuous Positive Airway Pressure CPAP; Other: Microcrystalline Cellulose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in 24-hour blood pressure

    Systolic, diastolic, and mean arterial blood pressure (mmHg)

    Measured: Change from baseline of 24-hour systolic, diastolic, and mean arterial blood pressure at 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2019
  2. Study startMay 2023 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Why it stopped: Covid-19 Pandemic prevented this study from beginning

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04021550
Sponsor's protocol ID
H18-03130
Status last verified
May 2023
First submitted
10 Jul 2019
Last updated
19 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Frampton JE. Telmisartan: a review of its use in cardiovascular disease prevention. Drugs. 2011 Apr 16;71(6):651-77. doi: 10.2165/11206710-000000000-00000.

    PubMed 21504246

  • Khayat RN, Varadharaj S, Porter K, Sow A, Jarjoura D, Gavrilin MA, Zweier JL. Angiotensin Receptor Expression and Vascular Endothelial Dysfunction in Obstructive Sleep Apnea. Am J Hypertens. 2018 Feb 9;31(3):355-361. doi: 10.1093/ajh/hpx174.

    PubMed 29036393

  • Khayat R, Patt B, Hayes D Jr. Obstructive sleep apnea: the new cardiovascular disease. Part I: Obstructive sleep apnea and the pathogenesis of vascular disease. Heart Fail Rev. 2009 Sep;14(3):143-53. doi: 10.1007/s10741-008-9112-z. Epub 2008 Sep 20.

    PubMed 18807180

  • Rotenberg BW, Murariu D, Pang KP. Trends in CPAP adherence over twenty years of data collection: a flattened curve. J Otolaryngol Head Neck Surg. 2016 Aug 19;45(1):43. doi: 10.1186/s40463-016-0156-0.

    PubMed 27542595

  • Pepin JL, Tamisier R, Barone-Rochette G, Launois SH, Levy P, Baguet JP. Comparison of continuous positive airway pressure and valsartan in hypertensive patients with sleep apnea. Am J Respir Crit Care Med. 2010 Oct 1;182(7):954-60. doi: 10.1164/rccm.200912-1803OC. Epub 2010 Jun 3.

    PubMed 20522795

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Continuous Positive Airway Pressure CPAP, Telmisartan 80mg and Alpha-Lipoic Acid 600mg in people with Obstructive Sleep Apnea, run by University of British Columbia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in 24-hour blood pressure (time frame: Change from baseline of 24-hour systolic, diastolic, and mean arterial blood pressure at 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04021550, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2023.

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