NCT00973531

Brief Summary

The investigators would like to investigate the effects of treating sleep apnea with a positive airway pressure device, either continuous (titrated) versus auto titrated on the control of blood pressure in patients with Resistant Hypertension.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started May 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

May 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2009

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 9, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

January 26, 2012

Status Verified

January 1, 2012

Enrollment Period

2.4 years

First QC Date

September 2, 2009

Last Update Submit

January 25, 2012

Conditions

Sleep ApneaHypertension

Keywords

Sleep Disordered BreathingSleep ApneaHypertensionContinuous Positive Airway Pressure

Outcome Measures

Primary Outcomes (1)

  • Noninferiority of the change from baseline to 90 day measurement in mean ambulatory 24-hour systolic ambulatory blood pressure in the Newer approach v/s Traditional Approach

    90 days

Secondary Outcomes (1)

  • Noninferiority of the change from baseline to 90 day measurement in mean ambulatory 24-hour diastolic ambulatory blood pressure in the Newer approach v/s Traditional Approach

    90 days

Study Arms (2)

Ambulatory APAP and SMT

OTHER

Subjects placed on the APAP machine

Device: Autotitrating Positive Airway Pressure (APAP)

Titration Polysomnogram with CPAP and SMT

OTHER

Subjects placed on CPAP machine

Device: Traditional Split Titration Polysomnogram

Interventions

Autotitrating Positive Airway Pressure (APAP)DEVICE

Then subjects will use Autotitrating Positive Airway Pressure machine for 90 days

Ambulatory APAP and SMT
Traditional Split Titration PolysomnogramDEVICE

Then subjects will use Continuous Positive Airway Pressure (CPAP) machine for 90 days

Titration Polysomnogram with CPAP and SMT

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects who are competent to provide written consent
  • Aged 18 to 80 years
  • Deemed to be compliant with anti-hypertension medication therapy.
  • Subjects with diabetes and/or chronic kidney disease must have a mean 24 hour systolic blood pressure ≥130 mmHg
  • All other subjects must have a mean 24 hour systolic blood pressure ≥140 mmHg
  • Receiving and adhering to full doses of appropriate guideline-recommended antihypertensive drugs from three different classes of antihypertensive agents, preferably including a diuretic

You may not qualify if:

  • Average sitting systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg
  • Known Sleep apnea
  • Subjects who perform alternating shift or night work
  • Subjects who have participated in a clinical study involving another investigational drug or device within 4 weeks prior to Screening
  • Have hypertension secondary to an identifiable and treatable cause other than sleep apnea
  • Subjects taking over the counter medications that can raise blood pressure, such as
  • Non narcotic analgesics
  • Non steroidal anti-inflammatory agents, including aspirin, Selective COX-2 inhibitors
  • Sympathomimetic agents (decongestants, diet pills, cocaine)
  • Stimulants (methylphenidate, dexmethylphenidate, dextroamphetamine, amphetamine, methamphetamine, modafinil)
  • Alcohol
  • Oral contraceptives
  • Cyclosporine
  • Erythropoietin
  • Natural licorice
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Albert Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

Location

MeSH Terms

Conditions

Sleep Apnea SyndromesHypertension

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Darshak Karia, MD

    Albert Einstein Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Albert Einstein Healthcare Network

Study Record Dates

First Submitted

September 2, 2009

First Posted

September 9, 2009

Study Start

May 1, 2009

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

January 26, 2012

Record last verified: 2012-01

Locations

US(1)