Endothelial Damage and Atherosclerosis in Obstructive Sleep Apnea

NCT00942643 | Terminated DMC

• 1 other identifier: HKCTR-772
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators hypothesize that obstructive sleep apnea (OSA) may lead to increased formation/accumulation of advanced glycation ends (AGEs), and that the increase in AGEs is contributed in part by increased insulin resistance. The investigators further hypothesize that AGEs contribute to vascular endothelial damage and ultimately atherosclerosis in OSA. The objectives of this study are:

1. 1.To explore the relationship between insulin resistance and AGEs in OSA
2. 2.To study the relationship between AGE and vascular endothelial dysfunction in OSA
3. 3.To study the relationship between AGE and early atherosclerosis in OSA

Conditions

Obstructive Sleep Apnea; Insulin Resistance; Endothelial Function; Oxidative Stress

Outcome Measures

Primary Outcomes (1)

• AGEs levels

  4 weeks and 12 weeks

Secondary Outcomes (1)

• endothelial function as assessed by reactive hyperemia-induced peripheral arterial tone response

  4 weeks and 12 weeks

Study Arms (2)

no treatment

NO INTERVENTION

being observed at 4 weeks and 12 weeks

CPAP treatment

ACTIVE COMPARATOR

a machine delivers positive airway pressure into the upper airway via nasal mask

Device: CPAP machine

Interventions

CPAP machine DEVICE

a machine delivers positive airway pressure into the upper airway via a nasal mask

Also known as: Continuous Positive Airway Pressure

CPAP treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18-65 years old
• AHI \>= 15
• BMI \< 35

You may not qualify if:

• Known cardiovascular disease, including hypertension
• Diabetes
• Acute or unstable chronic disease
• Renal failure
• Major organ system failure, including liver, renal, cardiac and respiratory failure
• Taking long-term medications

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Pokfulam, Pokfulam, Hong Kong

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Insulin Resistance

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Mary SM Ip, MD

  Queen Mary Hospital, The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Honorary clinical assistant professor

Study Record Dates

• First Submitted: July 20, 2009
• First Posted: July 21, 2009
• Study Start: May 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: July 4, 2012

Record last verified: 2012-07

Locations

HK (1)