Obstructive Sleep Apnea in World Trade Center Responders

NCT01753999 | Completed Results

• 2 other identifiers: 20120021641U01OH010415-01
• Study Type: interventional
• Target: 317
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of the study is to examine the possible underlying causes of sleep apnea (a disorder in which there are problems with breathing during sleep) in World Trade Center Responders. The study will look at the relationship between sleep apnea and various nose and throat conditions. Specifically, the study will look at upper airway disease (problems with the nose and throat), nasal inflammation, and nasal resistance (the amount of airflow through the nose). Subjects will have a physical exam and answer questions about nasal symptoms and sleeping problems. Nasal lavage (washing the inner nasal passages) will be performed on the subjects and markers of inflammation will be measured in the lavage fluid. Rhinomanometry (measuring the airflow through the nose) will also be performed to measure the degree of airflow obstruction. All subjects will be asked to perform in-home sleep apnea monitoring. Those subjects who are diagnosed with sleep apnea will test two treatment methods. Sleep apnea is treated by using a CPAP (continuous positive airway pressure) device. This device blows air into a mask worn by the patient during sleep. The two treatment methods that will be tested are the fixed pressure CPAP (pressure is constant during use) and CPAP-flex (pressure decreases when the subject exhales). Patients will be randomly assigned to one treatment method for one month then crossed to the other treatment method for the next month. The investigators will determine if patients with certain nasal conditions (high nasal resistance) are more likely to use CPAP-flex rather than CPAP.

Conditions

Obstructive Sleep Apnea

Keywords

World Trade Center (WTC); nasal symptoms; nasal inflammation; CPAP

Outcome Measures

Primary Outcomes (2)

• Adherence to CPAP Pre-crossover

  The use (number of hours per night) will be compared between standard CPAP and CPAP flex. Results are based on the first treatment period only (pre-crossover).

  5 weeks after initiation of treatment

• Adherence to CPAP Overall Study

  The use (number of hours per night) will be compared between standard CPAP and CPAP flex. Results are based on both periods.

  9 weeks after initiation of treatment

Secondary Outcomes (2)

• CPAP Efficacy

  5 weeks after initiation of treatment

• CPAP Efficacy

  9 weeks after initiation of treatment

Other Outcomes (2)

• Adherence to CPAP Overall Study, Subjects With High Nasal Resistance

  9 weeks after initiation of treatment

• Adherence to CPAP Overall Study, Subjects With Low Nasal Resistance

  9 weeks after initiation of treatment

Study Arms (2)

Standard CPAP

ACTIVE COMPARATOR

Use of a standard CPAP (continuous positive airway pressure) device with constant pressure for 4 weeks to improve breathing during sleep

Device: Standard CPAP

CPAP - Flex

ACTIVE COMPARATOR

Use of CPAP-Flex (continuous positive airway pressure) device with decreased pressure during expiration for 4 weeks to improve breathing during sleep

Device: CPAP - Flex

Interventions

Standard CPAP DEVICE

Use of the REMstar Auto A-Flex in standard CPAP therapy mode

Also known as: Philips Respironics REMstar Auto A-Flex

Standard CPAP

CPAP - Flex DEVICE

Use of Philips Respironics REMstar Auto A-Flex in C-Flex mode

Also known as: Philips Respironics REMstar Auto A-Flex

CPAP - Flex

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Member of the World Trade Center Health Program at either the Environmental and Occupational Healthy Sciences Institute at Robert Wood Johnson Medical School in Piscataway, NJ, the New York University School of Medicine Clinical Center of Excellence at Bellevue Hospital in New York, NY, or the Icahn School of Medicine at Mount Sinai.

You may not qualify if:

• Gross skeletal alterations affecting the upper airway (nose and throat)
• Unstable chronic medical conditions known to affect Obstructive Sleep Apnea (congestive heart failure, stroke)
• Pregnancy or intent to become pregnant
• Habitual snoring or diagnosis of obstructive sleep apnea prior to 9/11/2001.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• NYU Langone Health: collaborator

Study Sites (3)

Environmental and Occupational Health Sciences Institute

Piscataway, New Jersey, 08854, United States

Location

New York University School of Medicine Clinical Center of Excellence

New York, New York, 10016, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Related Publications (2)

• Sunderram J, Ayappa I, Lu SE, Wang H, Black K, Twumasi A, Sanders H, Harrison D, Udasin I, Chitkara N, de la Hoz RE, Carson JL, Rapoport DM. PAP Adherence and Nasal Resistance. A Randomized Controlled Trial of CPAPflex versus CPAP in World Trade Center Responders. Ann Am Thorac Soc. 2021 Apr;18(4):668-677. doi: 10.1513/AnnalsATS.202009-1161OC.

  PMID: 33202147 DERIVED

• Ayappa I, Sunderram J, Black K, Twumasi A, Udasin I, Harrison D, Carson JL, Lu SE, Rapoport DM. A comparison of CPAP and CPAPFLEX in the treatment of obstructive sleep apnea in World Trade Center responders: study protocol for a randomized controlled trial. Trials. 2015 Sep 10;16:403. doi: 10.1186/s13063-015-0907-7.

  PMID: 26357928 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: Dr. Jag Sunderram
• Organization: Rutgers Robert Wood Johnson Medical School

sunderja@rwjms.rutgers.edu

732-235-7038

Study Officials

• Jag Sunderram, MD

  Rutgers RWJMS

  PRINCIPAL INVESTIGATOR

• Indu Ayappa, PhD

  NYUMC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: Associate Professor

Study Record Dates

• First Submitted: December 17, 2012
• First Posted: December 21, 2012
• Study Start: December 1, 2012
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: April 30, 2025
• Results First Posted: July 20, 2018

Record last verified: 2025-04

Locations

US (3)