Metabolic Impact of Intermittent CPAP

NCT02824263 | Completed Results

• 2 other identifiers: NA_00086830R01HL135483
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

Obstructive sleep apnea is a risk factor for diabetes and cardiovascular disease, by unknown mechanisms. The investigators hypothesize that sleep apnea changes glucose and lipid metabolism during sleep, which over time could lead to diabetes and cardiovascular disease. This study examines metabolic changes during sleep in patients with obstructive sleep apnea. Patients accustomed to continuous positive airway pressure (CPAP) therapy are enrolled to undergo sleep studies, either on CPAP therapy or after withdrawing from CPAP for 3 nights. During sleep, blood samples are obtained so that metabolic function can be compared between sleep apnea and CPAP nights.

Conditions

Obstructive Sleep Apnea

Keywords

obstructive sleep apnea; CPAP; metabolism

Outcome Measures

Primary Outcomes (4)

• Concentration of Plasma Free Fatty Acids (FFA, mmol/L)

  We will report the mean for all participants per group (CPAP vs. CPAP withdrawal).

  2 nights, <1 month apart. Data from each night was averaged to report a single value.

• Concentration of Plasma Glucose (mg/dl)

  We will report the mean for all participants per group (CPAP vs. CPAP withdrawal).

  2 nights, <1 month apart. Data from each night was averaged to report a single value.

• Concentration of Plasma Insulin (mcU/ml)

  We will report the mean for all participants per group (CPAP vs. CPAP withdrawal).

  2 nights, <1 month apart. Data from each night was averaged to report a single value.

• Concentration of Plasma Triglycerides (mg/dl)

  We will report the mean for all participants per group (CPAP vs. CPAP withdrawal).

  2 nights, <1 month apart. Data from each night was averaged to report a single value.

Secondary Outcomes (3)

• Oral Glucose Tolerance Test (OGTT)

  2 nights, <1 month apart. 5 OGTT values were averaged to a obtain a single value.

• Reactive Hyperemia Index (RHI)

  2 nights, <1 month apart, 1 measurement each visit

• Augmentation Index (AI)

  2 nights, <1 month apart, 1 measurement each visit

Study Arms (2)

CPAP (Usual care)

NO INTERVENTION

Continuation of established CPAP therapy. CPAP will be worn during a metabolic sleep study in the research laboratory.

CPAP withdrawal;

EXPERIMENTAL

Cessation of established CPAP therapy for 3 nights. CPAP will NOT be worn during this period, and a metabolic sleep study off CPAP is performed in the research laboratory on the third night.

Other: CPAP withdrawal

Interventions

CPAP withdrawal OTHER

CPAP is discontinued for 3 nights.

CPAP withdrawal;

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of moderate to severe Obstructive sleep apnea (OSA) (AHI or respiratory disturbance index (RDI)\> 10).
• They must also own a CPAP machine and report the ability to tolerate sleeping with or without CPAP during the night.

You may not qualify if:

• Uncontrolled hypertension with systolic blood pressure \>170 or diastolic blood pressure \> 110
• Congestive heart failure
• Use of clonidine or nicotinic acid medication
• Diabetes requiring the use of insulin
• Known pregnancy, by urine testing in women of child-bearing age
• History of falling asleep while driving, near miss
• High risk occupation (pilot, commercial driver)
• Hemoglobin \< 10 g/dL on point of care screening

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• American Academy of Sleep Medicine: collaborator

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Related Publications (1)

• Chopra S, Rathore A, Younas H, Pham LV, Gu C, Beselman A, Kim IY, Wolfe RR, Perin J, Polotsky VY, Jun JC. Obstructive Sleep Apnea Dynamically Increases Nocturnal Plasma Free Fatty Acids, Glucose, and Cortisol During Sleep. J Clin Endocrinol Metab. 2017 Sep 1;102(9):3172-3181. doi: 10.1210/jc.2017-00619.

  PMID: 28595341 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: Jonathan Jun
• Organization: Johns Hopkins University School of Medicine

jjun2@jhmi.edu

410-550-0115

Study Officials

• Jonathan C Jun, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2016
• First Posted: July 6, 2016
• Study Start: July 10, 2016
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 2, 2024
• Results First Posted: January 2, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)