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

NCT ID: NCT00881985

Last Updated: 2019-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2019-07-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Resistant Hypertension Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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continuous positive airway pressure

Group Type ACTIVE_COMPARATOR

continuous positive airway pressure

Intervention Type DEVICE

Use CPAP whenever sleep

observation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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continuous positive airway pressure

Use CPAP whenever sleep

Intervention Type DEVICE

Other Intervention Names

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CPAP

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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The University of Hong Kong

Principal Investigators

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Mary SM Ip, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

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Queen Mary Hospital

Hong Kong, , China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 10770144 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9250236 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11812555 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12515745 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16585412 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18391085 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11725173 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10872551 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11560187 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12608436 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17301092 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33795324 (View on PubMed)

Other Identifiers

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UW 09-051

Identifier Type: -

Identifier Source: org_study_id

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