NCT00607893

Brief Summary

Sleep-disordered breathing (SDB) is a condition in which a person experiences frequent breathing pauses during sleep, also known as sleep apnea. There is evidence that the recurrent sleep arousal and associated shortage of oxygen in the body may increase risk for cardiovascular disease (CVD). It is believed that treatment with continuous positive airway pressure (CPAP) may reduce certain risk factors for heart disease, including markers of inflammation and oxidative stress. This study will evaluate the effectiveness of CPAP in reducing CVD risk factors in people with SDB.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
153

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2006

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 6, 2008

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
6.2 years until next milestone

Results Posted

Study results publicly available

September 15, 2017

Completed
Last Updated

September 15, 2017

Status Verified

August 1, 2017

Enrollment Period

4.8 years

First QC Date

January 25, 2008

Results QC Date

April 6, 2017

Last Update Submit

August 17, 2017

Conditions

Sleep Apnea SyndromesOxidative StressCardiovascular Diseases

Keywords

Sleep-Disordered Breathing

Outcome Measures

Primary Outcomes (2)

  • F2-isoprostanes/Cr

    Oxidative stress outcome, analyzed absolute change from baseline, with adjustment of baseline

    Measured between baseline and after treatment

  • Myeloperoxidase

    Oxidative stress outcome, analyzed absolute change from baseline, with adjustment of baseline

    Measured between baseline and after treatment

Secondary Outcomes (8)

  • Mean Arterial BP, Evening

    Measured between baseline and after treatment

  • Pulse Wave Velocity, Evening

    Measured between baseline and after treatment

  • IL-6

    Measured between baseline and after treatment

  • Mean Arterial BP, Morning

    Measured between baseline and after treatment

  • sIL-6R

    Measured between baseline and after treatment

  • +3 more secondary outcomes

Study Arms (2)

Sham CPAP

SHAM COMPARATOR

Participants will receive sham continuous positive airway pressure (CPAP) for a 2 month period. Sham CPAP involves wearing a device that appears similar to a standard CPAP device, but administers a negligible pressure. Adherence will be tracked while the participant wears the device.

Device: Sham CPAP

Treatment CPAP

ACTIVE COMPARATOR

Participants will receive continuous positive airway pressure for a 2 month period. The optimal treatment pressure will be identified during a titration study prior to trial enrollment. Adherence will be tracked while the participant wears the device.

Device: Continuous Positive Airway Pressure (CPAP)

Interventions

Continuous Positive Airway Pressure (CPAP)DEVICE

Participants will use the higher pressure CPAP, as determined by an in-laboratory attended titration study, every night for 12 weeks.

Treatment CPAP
Sham CPAPDEVICE

Participants will use the lower pressure CPAP every night for 8 weeks.

Sham CPAP

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Moderate to severe sleep disordered breathing (SDB) (Apnea Hypopnea Index \[AHI\] greater than or equal to 15) diagnosed within the 2 months before study entry
  • Able to participate in more than two overnight/daytime sleep and physiologic assessments over a 2.5-month period

You may not qualify if:

  • Current or planned use of specific sleep apnea treatments (e.g., CPAP, oral appliance) outside of the study
  • Anticipated upper airway surgery or gastric bypass surgery in the 4 months after study completion
  • Supplemental oxygen use
  • Primary sleep disorder other than sleep apnea (e.g., periodic limb movement disorder)
  • Severe chronic insomnia or circadian rhythm disorder with less than 4 hours of sleep per night, chronic problems falling asleep within 1 hour of bedtime, or chronic problems with early morning awakenings
  • Unstable medical conditions (e.g., new onset or changing angina; heart attack or congestive heart failure exacerbation documented within the 6 months before study entry; high grade cardiac dysrhythmia/heart block; known unaddressed coronary artery disease by history, angina, stroke, or uncontrolled hypertension or diabetes mellitus; thyroid disorder; cirrhosis; a non-skin cancer diagnosed within the 2 years before study entry)
  • Inadequately treated psychiatric disorders or compromised competence
  • Daytime sleepiness with reports of sleepiness while driving or during other situations that would present a risk for the subject or public (e.g., operating heavy equipment)
  • Alcohol abuse
  • Pregnancy
  • Use of oral corticosteroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (7)

  • Mehra R, Storfer-Isser A, Kirchner HL, Johnson N, Jenny N, Tracy RP, Redline S. Soluble interleukin 6 receptor: A novel marker of moderate to severe sleep-related breathing disorder. Arch Intern Med. 2006 Sep 18;166(16):1725-31. doi: 10.1001/archinte.166.16.1725.

    PMID: 16983050BACKGROUND

  • Mehra R, Principe-Rodriguez K, Kirchner HL, Strohl KP. Sleep apnea in acute coronary syndrome: high prevalence but low impact on 6-month outcome. Sleep Med. 2006 Sep;7(6):521-8. doi: 10.1016/j.sleep.2006.03.012. Epub 2006 Aug 23.

    PMID: 16931151BACKGROUND

  • Mehra R, Benjamin EJ, Shahar E, Gottlieb DJ, Nawabit R, Kirchner HL, Sahadevan J, Redline S; Sleep Heart Health Study. Association of nocturnal arrhythmias with sleep-disordered breathing: The Sleep Heart Health Study. Am J Respir Crit Care Med. 2006 Apr 15;173(8):910-6. doi: 10.1164/rccm.200509-1442OC. Epub 2006 Jan 19.

    PMID: 16424443BACKGROUND

  • May AM, Wang L, Strohl KP, Walia H, Hazen SL, Mehra R. Sex-Specific Differential Responses of Circulating Biomarkers in Obstructive Sleep Apnea Treatment. A Post Hoc Analysis of a Randomized Controlled Trial. Ann Am Thorac Soc. 2020 May;17(5):605-613. doi: 10.1513/AnnalsATS.201908-593OC.

    PMID: 31860326DERIVED

  • May AM, Gharibeh T, Wang L, Hurley A, Walia H, Strohl KP, Mehra R. CPAP Adherence Predictors in a Randomized Trial of Moderate-to-Severe OSA Enriched With Women and Minorities. Chest. 2018 Sep;154(3):567-578. doi: 10.1016/j.chest.2018.04.010. Epub 2018 Apr 21.

    PMID: 29684316DERIVED

  • DeMartino T, Ghoul RE, Wang L, Bena J, Hazen SL, Tracy R, Patel SR, Auckley D, Mehra R. Oxidative Stress and Inflammation Differentially Elevated in Objective Versus Habitual Subjective Reduced Sleep Duration in Obstructive Sleep Apnea. Sleep. 2016 Jul 1;39(7):1361-9. doi: 10.5665/sleep.5964.

    PMID: 27091532DERIVED

  • Paz Y Mar HL, Hazen SL, Tracy RP, Strohl KP, Auckley D, Bena J, Wang L, Walia HK, Patel SR, Mehra R. Effect of Continuous Positive Airway Pressure on Cardiovascular Biomarkers: The Sleep Apnea Stress Randomized Controlled Trial. Chest. 2016 Jul;150(1):80-90. doi: 10.1016/j.chest.2016.03.002. Epub 2016 Mar 18.

    PMID: 26997243DERIVED

MeSH Terms

Conditions

Sleep Apnea SyndromesCardiovascular Diseases

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Results Point of Contact

Title
Reena Mehra
Organization
Case Western Reserve University
mehrar@ccf.org
216-445-1698

Study Officials

  • Reena Mehra, MD, MS

    University Hospitals Cleveland Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 25, 2008

First Posted

February 6, 2008

Study Start

September 1, 2006

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

September 15, 2017

Results First Posted

September 15, 2017

Record last verified: 2017-08

Locations

US(1)