NCT00694616

Brief Summary

Metabolic syndrome is a constellation of risk factors for cardiovascular disease. The prevalence of metabolic syndrome in persons with obstructive sleep apnea syndrome (OSAS) is known to be very high, about 70%. However, it is unclear whether this association is causal or not. Results of earlier studies have been conflicting. The investigators hypothesize that treatment with auto-titrating continuous positive airway pressure (auto-CPAP) for a duration of 3 months improves the metabolic syndrome in subjects with OSAS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2008

Typical duration 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

First Submitted

Initial submission to the registry

June 5, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 10, 2008

Completed
21 days until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

June 25, 2013

Status Verified

June 1, 2013

Enrollment Period

1.8 years

First QC Date

June 5, 2008

Last Update Submit

June 22, 2013

Conditions

Obstructive Sleep ApneaMetabolic Syndrome

Keywords

Obstructive sleep apneaMetabolic syndromeInsulin resistanceHypertensionDyslipidemiaContinuous positive airway pressure (CPAP)

Outcome Measures

Primary Outcomes (1)

  • Proportion of subjects satisfying the National Cholesterol Education Program-Adult Treatment Panel (NCEP-ATP III) criteria for the diagnosis of metabolic syndrome

    3 months

Secondary Outcomes (1)

  • Individual components of the NCEP-ATP III criteria (FBS, BP, LDL cholesterol, HDL cholesterol, triglycerides) and insulin resistance (assessed by HOMA-IR)

    3 months

Study Arms (2)

1

OTHER

3 months of therapeutic CPAP (auto-titrating CPAP) followed by 3 months of non-therapeutic sham-CPAP with 1 month of wash-out in between

Device: AutoSet Spirit

2

OTHER

3 months of non-therapeutic sham-CPAP followed by 3 months of therapeutic CPAP (auto-titrating CPAP) with 1 month of wash-out in between

Device: Modified-AutoSet Spirit

Interventions

AutoSet SpiritDEVICE

3 months of therapeutic CPAP (auto-titrating CPAP) followed by 3 months of non-therapeutic sham-CPAP with 1 month of wash-out in between

Also known as: AutoSet Spirit(TM), ResMed India Ltd.
1
Modified-AutoSet SpiritDEVICE

3 months of non-therapeutic sham-CPAP followed by 3 months of therapeutic CPAP (auto-titrating CPAP) with 1 month of wash-out in between

Also known as: Modified-AutoSet Spirit(TM), ResMed India Ltd.
2

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with moderately severe OSAS (AHI \>= 15 with excessive daytime sleepiness) also having metabolic syndrome, and have never received treatment for OSAS, diabetes mellitus and hypertension

You may not qualify if:

  • Diabetic subjects will be excluded if any one of the following is present
  • Proliferative diabetic retinopathy
  • Nephropathy (serum creatinine \>1.8 mg/dL)
  • Clinically manifest neuropathy defined as absent ankle jerks.
  • Severe hyperglycemia (FBS \>200 mg/dL)
  • Hypertensive subjects will be excluded if any one of the following is present
  • Symptomatic coronary artery disease
  • Symptomatic peripheral vascular disease
  • Past history of cerebrovascular accident
  • Known case of aortic aneurysm or left ventricular dysfunction
  • Nephropathy (serum creatinine \>1.8 mg/dL)
  • Marked elevation in blood pressure (BP \>180/110 mm Hg on two occasions)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

All India Institute of Medical Sciences

New Delhi, New Delhi, 110608, India

Location

Related Publications (1)

  • Sharma SK, Agrawal S, Damodaran D, Sreenivas V, Kadhiravan T, Lakshmy R, Jagia P, Kumar A. CPAP for the metabolic syndrome in patients with obstructive sleep apnea. N Engl J Med. 2011 Dec 15;365(24):2277-86. doi: 10.1056/NEJMoa1103944.

    PMID: 22168642DERIVED

MeSH Terms

Conditions

Sleep Apnea, ObstructiveMetabolic SyndromeInsulin ResistanceHypertensionDyslipidemias

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesVascular DiseasesCardiovascular DiseasesLipid Metabolism Disorders

Study Officials

  • Surendra K Sharma, M.D., Ph.D.

    All India Institute of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 5, 2008

First Posted

June 10, 2008

Study Start

July 1, 2008

Primary Completion

May 1, 2010

Study Completion

December 1, 2010

Last Updated

June 25, 2013

Record last verified: 2013-06

Locations

IN(1)