NCT01138865

Brief Summary

CPAP, the standard treatment for Obstructive sleep apnea syndrome (OSAS) that reduces sleep fragmentations and neurocognitive deficit in OSAS may also have a key role in reduction of cardiovascular, mortality risks in the same patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2012

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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 2, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 8, 2010

Completed
1.7 years until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

June 24, 2013

Status Verified

June 1, 2013

Enrollment Period

2.5 years

First QC Date

June 2, 2010

Last Update Submit

June 21, 2013

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive sleep apneaCytokine levelsInsulin resistanceHypertensionDyslipidemiaAlbumin-creatinine ratioContinuous positive airway pressure (CPAP)

Outcome Measures

Primary Outcomes (5)

  • Effect of CPAP therapy on blood pressure

    7 months

  • Effect of CPAP therapy on insulin resistance

    7months

  • Effect of CPAP therapy on plasma hs-CRP

    7months

  • Effect of CPAP therapy on lipid profile

    7months

  • Effect of CPAP therapy on urinary albumin-creatinine ratio

    7months

Secondary Outcomes (5)

  • Effect of CPAP on anthropometric parameters

    3 months

  • Effect of CPAP on visceral fat and other imagings

    3months

  • Effect of CPAP on carotid intima medical thickness

    3months

  • Effect of CPAP on adipokines and oxidative stress markers

    3months

  • Effect of CPAP on inflammatory cytokine levels.

    3months

Study Arms (2)

1

OTHER

Device: AutoSet Spirit--Wash--Modified-AutoSet Spirit 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--Wash--Modified-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--Wash-AutoSet Spirit

Interventions

AutoSet Spirit--Wash--Modified-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 Spirit--Wash-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:

  • The 1st part of the study will include
  • males and females, aged 30-65 years,
  • with AHI \>5 and excessive daytime sleepiness
  • naïve to CPAP treatment.
  • Subjects from first part of the study who have moderately severe OSAS and have never received treatment for OSA,diabetes mellitus and hypertension

You may not qualify if:

  • Hypothyroidism
  • Chronic renal failure
  • Chronic liver disease
  • Chronic lung disease
  • Known systemic inflammatory diseases (lupus , sarcoidosis and other connective tissue disorders),
  • Use of drugs that influence urinary protein excretion (eg. steroids, lithium, NSAIDS, ACE inhibitors/Angiotensin Receptor Blockers etc.)
  • Immune deficiency conditions
  • Pregnancy
  • Active menstruation at time of sampling
  • Macroalbuminuria (aACR\>300mg/g),
  • Patients of coronary artery disease and left ventricular dysfunction
  • Not on treatment for hypertension, diabetes mellitus or dyslipidemia
  • Long lasting hypertension or diabetes mellitus (more than 5 years after diagnosis)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, 110029, India

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, ObstructiveInsulin 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, MD,Ph.D

    All India Institute of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Surendra K Sharma, MD, Ph.D

CONTACT

91-11-26594415sksharma@aiims.ac.in

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Haed

Study Record Dates

First Submitted

June 2, 2010

First Posted

June 8, 2010

Study Start

March 1, 2012

Primary Completion

September 1, 2014

Study Completion

March 1, 2015

Last Updated

June 24, 2013

Record last verified: 2013-06

Locations

IN(1)