The Effects of Treating Obese and Lean Patients With Sleep Apnea

NCT01578031 | Completed Results DMC

• 1 other identifier: NIH P02 HL094307-01
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators' overall goal is to compare the effect of CPAP treatment on intermediate cardiovascular risk measures in obese versus lean patients with obstructive sleep apnea (OSA). The overall hypothesis is that, adjusting for OSA severity and obtaining normative data from non-OSA subjects with comparable amounts of visceral adiposity, the two OSA groups will have comparable improvements in daytime sleepiness, but that the cardiovascular and metabolic improvements following CPAP therapy will be decreased in OSA patients with increased visceral adipose tissue. The investigators anticipate that, although there will be a greater absolute change in markers of sympathetic activity, inflammation and oxidative stress in obese compared to lean OSA patients following CPAP treatment, the levels will still be abnormally high in the obese patients resulting in the decreased improvements in insulin resistance, arterial blood pressure, and vascular health in obese versus lean OSA patients.

Conditions

Sleep Apnea; Obesity

Keywords

Sleep Apnea; Obesity

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Mean Arterial Blood Pressure

  Change in mean 24-hour ambulatory blood pressure from baseline following 4-months of PAP treatment

  4 months

Secondary Outcomes (4)

• Change From Baseline in Psychomotor Vigilance Task

  4 months

• Change From Baseline in Sympathetic Nervous System Activity

  4 months

• Change From Baseline in Circulating Inflammatory Biomarker

  4 months

• Change From Baseline in Oxidative Stress

  4 months

Study Arms (4)

Obese Patients with Obstructive Sleep Apnea

ACTIVE COMPARATOR

Obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment.

Device: Positive Airway Pressure During Sleep (ResMed S9 Elite)

Non-obese Patients with Obstructive Sleep Apnea

ACTIVE COMPARATOR

Non-obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment.

Device: Positive Airway Pressure During Sleep (ResMed S9 Elite)

Obese subjects without OSA

OTHER

Control.

Other: Usual Care

Non-obese subjects without OSA

OTHER

Control.

Other: Usual Care

Interventions

Positive Airway Pressure During Sleep (ResMed S9 Elite) DEVICE

Positive airway pressure during sleep (ResMed S9 Elite).

Non-obese Patients with Obstructive Sleep Apnea; Obese Patients with Obstructive Sleep Apnea

Usual Care OTHER

Usual care.

Non-obese subjects without OSA; Obese subjects without OSA

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 40-65 years; Will only recruit post-menopausal women not on hormone replacement therapy to avoid the potential confounding effects of female hormones on OSA prevalence and severity, fat distribution as well as the end-points (50-60)
• Lean subjects need to have a waist circumference score \<= 107 cm in men and \<= 96 cm in women.
• Obese subjects need to have a waist circumference score \> 107 cm in men and \> 96 cm in women
• For OSA volunteers, 15 ≤ AHI ≤ 75 (see Preliminary Results for justification of upper limit) on full-night in-laboratory polysomnogram within the last 6 months.
• Stable medical history and no change in medications, including anti-hypertensive and lipid-lowering medications, in the previous 2 months
• No regular daytime use (\> 3 times/week) of sedative or hypnotic medications in the last 2 months
• Arm circumference ≤ 50 cm (manufacturer limit for performing ambulatory BP recording)

You may not qualify if:

• Unable or unwilling to provide informed consent.
• Not satisfied with reimbursement
• Time constraints
• No telephone access or inability to return for follow up testing.
• BMI \> 40 kg/m2.
• Diagnosis of another sleep disorder in addition to OSA based on PSG (e.g., periodic limb movement disorder \[≥ 15 limb movements/hour of sleep with arousal\], central sleep apnea \[≥ 50% of apneas on diagnostic PSG are central apneas\], insomnia, restless legs syndrome obesity hypoventilation syndrome, or narcolepsy).
• Previous treatment with positive airway pressure, home oxygen therapy, tracheotomy, uvulopalatopharyngoplasty, or other surgery for OSA
• Requiring oxygen or bi-level positive airway pressure for treatment of OSA.
• A clinically unstable medical condition as defined by a new diagnosis or change in medical management in the previous 2 months (e.g., myocardial infarction, congestive heart failure, Cheyne-Stokes breathing, unstable angina, thyroid disease, depression or psychosis, ventricular arrhythmias, cirrhosis, surgery, or recently diagnosed cancer)
• Positive urine toxicology screen
• Rotating Night shift workers in situations or occupations where they regularly experience jet lag, or have irregular work schedules by history over the last 6 months.
• Routine consumption of more than 2 alcoholic beverages per day as determined by the CAGE questionnaire (63-65).
• Unable to perform tests due to inability to communicate verbally, inability to write and read in English; less than a 5th grade reading level; visual, hearing or cognitive impairment (e.g. previous head injury); or upper extremity motor deficit (e.g., previous stroke that prevents patient from using CPAP treatment).
• Current illicit drug use
• Excessive caffeine use (More than 10 caffeinated beverages per day)

Sponsors & Collaborators

• University of Pennsylvania: lead
• University of Iceland: collaborator

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (3)

• Imayama I, Gupta A, Yen PS, Chen YF, Keenan B, Townsend RR, Chirinos JA, Weaver FM, Carley DW, Kuna ST, Prasad B. Socioeconomic status impacts blood pressure response to positive airway pressure treatment. J Clin Sleep Med. 2022 May 1;18(5):1287-1295. doi: 10.5664/jcsm.9844.

  PMID: 34931603 DERIVED

• Xu L, Keenan BT, Maislin D, Gislason T, Benediktsdottir B, Gudmundsdottir S, Gardarsdottir M, Staley B, Pack FM, Guo X, Feng Y, Chahwala J, Manaktala P, Hussein A, Reddy-Koppula M, Hashmath Z, Lee J, Townsend RR, Schwab RJ, Pack AI, Kuna ST, Chirinos JA. Effect of Obstructive Sleep Apnea and Positive Airway Pressure Therapy on Cardiac Remodeling as Assessed by Cardiac Biomarker and Magnetic Resonance Imaging in Nonobese and Obese Adults. Hypertension. 2021 Mar 3;77(3):980-992. doi: 10.1161/HYPERTENSIONAHA.120.15882. Epub 2021 Jan 19.

  PMID: 33461313 DERIVED

• Feng Y, Maislin D, Keenan BT, Gislason T, Arnardottir ES, Benediktsdottir B, Chirinos JA, Townsend RR, Staley B, Pack FM, Sifferman A, Pack AI, Kuna ST. Physical Activity Following Positive Airway Pressure Treatment in Adults With and Without Obesity and With Moderate-Severe Obstructive Sleep Apnea. J Clin Sleep Med. 2018 Oct 15;14(10):1705-1715. doi: 10.5664/jcsm.7378.

  PMID: 30353806 DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes; Obesity

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Samuel T. Kuna, MD
• Organization: University of Pennsylvania

skuna@mail.med.upenn.edu

215-823-4400

Study Officials

• Samuel Kuna, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2012
• First Posted: April 16, 2012
• Study Start: March 1, 2009
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: July 5, 2019
• Results First Posted: May 18, 2017

Record last verified: 2019-06

Locations

US (1)