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Resistant HypertensionNCT00881985

Effect of Continuous Positive Airway Pressure for Treatment of Obstructive Sleep Apnea on Resistant Hypertension

A study testing continuous positive airway pressure in people with Resistant Hypertension and Obstructive Sleep Apnea, run by The University of Hong Kong at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objectives of this study are to investigate the effect of continuous positive airway pressure (CPAP) treatment on blood pressure control and vascular inflammation in subjects with resistant hypertension and moderate obstructive sleep apnea (OSA). Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
continuous positive airway pressure
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
1 siteChina
Study dates
Mar 2009to Jul 2019
Phase
Interventional
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

  • Age 18 - 65
  • known hypertension on ≧ 3 anti-hypertensive drugs
  • Apnea-hypopnea index ≧15
  • able to give informed written consent

Who cannot join

  • moderate renal impairment (glomerular filtration rate <30 mL/min/m2 )
  • endocrine/renal/cardiac causes of secondary HT
  • congestive heart failure and clinically fluid overloaded
  • On drugs that elevates BP e.g. NSAID, steroid
  • Non-compliance to anti-hypertensive medications
  • Unstable medical conditions such as unstable angina, recent myocardial infarction/stroke within 3 months
Show all 9Show fewer
  • Active inflammatory/infective conditions e.g. rheumatoid arthritis
  • Excessive sleepiness that can be risky e.g. occupational driver, machine operator
  • Modification/changes of anti-hypertensive regimen within 8 weeks

Trial locations and contacts

1 site in 1 country.

China1 site

  • Queen Mary Hospital

    Hong Kong, 852

Other trials in China

About this study

Official title: Effect of Continuous Positive Airway Pressure for Treatment of Obstructive Sleep Apnea on Drug-resistant Hypertension : A Randomized Controlled Trial

The objectives of this study are to investigate the effect of continuous positive airway pressure (CPAP) treatment on blood pressure control and vascular inflammation in subjects with resistant hypertension and moderate obstructive sleep apnea (OSA).

Read the detailed description

Resistant hypertension is defined as blood pressure that remains above goal in spite of concurrent use of 3 antihypertensive agents of different classes. Resistant hypertension is defined in order to identify patients who are at risk of having secondary causes of hypertension, and who may benefit from specific diagnostic and therapeutic applications. Despite the fact that OSA is listed as one of the causes of resistant HT , paucity of works has demonstrated the magnitude of problems of untreated OSA in subjects with resistant HT. There is so far two study demonstrating the beneficial effect of CPAP treatment in subjects with resistant HT, though both studies were flawed by not including the control group, no randomization and limited sample size. We aim at conducting a randomized controlled study to explore the beneficial effect of CPAP treatment in subjects with OSA and resistant hypertension.

Being tested
continuous positive airway pressure
Keywords
obstructive sleep apnea, resistant hypertension, refractory hypertension, continuous positive airway pressure, blood pressure control
Medical subject headings
Sleep Apnea, Obstructive, Hypertension

What participants receive

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

  • continuous positive airway pressureDevice

    Also called CPAP

    Use CPAP whenever sleep

Study groups in NCT00881985
Study groupRoleWhat they receive
continuous positive airway pressureActive comparatorNot described
Receives: Device: continuous positive airway pressure
observationNo interventionNot described

What is being measured

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

  1. mean systolic blood pressure

    Measured: 8 weeks

Secondary outcomes (5)

  1. mean arterial blood pressure

    Measured: 8 weeks

  2. mean diastolic blood pressure

    Measured: 8 weeks

  3. high sensitivity C-reactive protein

    Measured: 8 weeks

  4. cardiac injury marker

    Measured: 8 weeks

  5. oxidative stress marker

    Measured: 8 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 Apr 2009 (estimated)
  2. Study startMar 2009
  3. Primary completionJul 2019
  4. Study completionJul 2019

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
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00881985
Sponsor's protocol ID
UW 09-051
Status last verified
Sep 2019
First submitted
14 Apr 2009
Last updated
2 Oct 2019
Results posted
No

Publications

  • Nieto FJ, Young TB, Lind BK, Shahar E, Samet JM, Redline S, D'Agostino RB, Newman AB, Lebowitz MD, Pickering TG. Association of sleep-disordered breathing, sleep apnea, and hypertension in a large community-based study. Sleep Heart Health Study. JAMA. 2000 Apr 12;283(14):1829-36. doi: 10.1001/jama.283.14.1829.

    PubMed 10770144

  • Young T, Peppard P, Palta M, Hla KM, Finn L, Morgan B, Skatrud J. Population-based study of sleep-disordered breathing as a risk factor for hypertension. Arch Intern Med. 1997 Aug 11-25;157(15):1746-52.

    PubMed 9250236

  • Pepperell JC, Ramdassingh-Dow S, Crosthwaite N, Mullins R, Jenkinson C, Stradling JR, Davies RJ. Ambulatory blood pressure after therapeutic and subtherapeutic nasal continuous positive airway pressure for obstructive sleep apnoea: a randomised parallel trial. Lancet. 2002 Jan 19;359(9302):204-10. doi: 10.1016/S0140-6736(02)07445-7.

    PubMed 11812555

  • Becker HF, Jerrentrup A, Ploch T, Grote L, Penzel T, Sullivan CE, Peter JH. Effect of nasal continuous positive airway pressure treatment on blood pressure in patients with obstructive sleep apnea. Circulation. 2003 Jan 7;107(1):68-73. doi: 10.1161/01.cir.0000042706.47107.7a.

    PubMed 12515745

  • Norman D, Loredo JS, Nelesen RA, Ancoli-Israel S, Mills PJ, Ziegler MG, Dimsdale JE. Effects of continuous positive airway pressure versus supplemental oxygen on 24-hour ambulatory blood pressure. Hypertension. 2006 May;47(5):840-5. doi: 10.1161/01.HYP.0000217128.41284.78. Epub 2006 Apr 3.

    PubMed 16585412

  • Calhoun DA, Jones D, Textor S, Goff DC, Murphy TP, Toto RD, White A, Cushman WC, White W, Sica D, Ferdinand K, Giles TD, Falkner B, Carey RM. Resistant hypertension: diagnosis, evaluation, and treatment. A scientific statement from the American Heart Association Professional Education Committee of the Council for High Blood Pressure Research. Hypertension. 2008 Jun;51(6):1403-19. doi: 10.1161/HYPERTENSIONAHA.108.189141. Epub 2008 Apr 7.

    PubMed 18391085

  • Logan AG, Perlikowski SM, Mente A, Tisler A, Tkacova R, Niroumand M, Leung RS, Bradley TD. High prevalence of unrecognized sleep apnoea in drug-resistant hypertension. J Hypertens. 2001 Dec;19(12):2271-7. doi: 10.1097/00004872-200112000-00022.

    PubMed 11725173

  • Grote L, Hedner J, Peter JH. Sleep-related breathing disorder is an independent risk factor for uncontrolled hypertension. J Hypertens. 2000 Jun;18(6):679-85. doi: 10.1097/00004872-200018060-00004.

    PubMed 10872551

  • Lavie P, Hoffstein V. Sleep apnea syndrome: a possible contributing factor to resistant. Sleep. 2001 Sep 15;24(6):721-5. doi: 10.1093/sleep/24.6.721.

    PubMed 11560187

  • Logan AG, Tkacova R, Perlikowski SM, Leung RS, Tisler A, Floras JS, Bradley TD. Refractory hypertension and sleep apnoea: effect of CPAP on blood pressure and baroreflex. Eur Respir J. 2003 Feb;21(2):241-7. doi: 10.1183/09031936.03.00035402.

    PubMed 12608436

  • Martinez-Garcia MA, Gomez-Aldaravi R, Soler-Cataluna JJ, Martinez TG, Bernacer-Alpera B, Roman-Sanchez P. Positive effect of CPAP treatment on the control of difficult-to-treat hypertension. Eur Respir J. 2007 May;29(5):951-7. doi: 10.1183/09031936.00048606. Epub 2007 Feb 14.

    PubMed 17301092

  • Lui MM, Tse HF, Lam DC, Lau KK, Chan CW, Ip MS. Continuous positive airway pressure improves blood pressure and serum cardiovascular biomarkers in obstructive sleep apnoea and hypertension. Eur Respir J. 2021 Nov 4;58(5):2003687. doi: 10.1183/13993003.03687-2020. Print 2021 Oct.

    PubMed 33795324

Questions about this trial

What is this clinical trial studying?

A study testing continuous positive airway pressure in people with Resistant Hypertension and Obstructive Sleep Apnea, run by The University of Hong Kong at 1 site in China.

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 4 inclusion and 9 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: finished, as of the sponsor's last update on 2 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

mean systolic blood pressure (time frame: 8 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 NCT00881985, which also lists 12 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 2 Oct 2019.

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