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Early Diagnosis and Treatment of Sleep Disordered Breathing in Lung Cancer

NCT ID: NCT03443908

Last Updated: 2021-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-17

Study Completion Date

2019-05-13

Brief Summary

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Sleep-disordered breathing at night is a common medical problem. It leads to daytime fatigue, impairment in concentration and daily activities, and a higher risk of cardiovascular disease and life-threatening events. A particularly common form is obstructive sleep apnea (OSA), and it is usually treatable with a high rate of patient satisfaction and improved quality of life using a continuous positive airway pressure (CPAP) device.

Treatment of this condition improves nighttime low-oxygen levels by ensuring patency of the upper airways. Research shows that in cancer, sleep disordered breathing is frequent. Low oxygen levels overnight may cause tumors to grow: tumors deprived of oxygen grow more blood vessels to try to get more oxygen, and growing more blood vessels makes the tumor grow. This study aims to examine how treating sleep-disordered breathing may lessen blood-flow to lung tumors, and thus serve to ultimately block tumor growth.

Participants of this study will undergo sleep study and receive CPAP therapy as a part of routine care.

Detailed Description

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Conditions

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Lung Cancer

Keywords

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lung cancer non small cell lung cancer nsclc small cell lung cancer sclc metastic lung mass sleep disordered breathing sdb obstructive sleep apnea

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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CPAP therapy

CPAP therapy (minimum of 3-4 weeks)

CPAP

Intervention Type DEVICE

CPAP therapy 3-4 weeks

Interventions

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CPAP

CPAP therapy 3-4 weeks

Intervention Type DEVICE

Other Intervention Names

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continuous positive airway pressure

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of lung cancer in one of 2 sub-types:

1. newly diagnosed early-stage tumor
2. advanced-stage lung tumor undergoing serial contrast-CT imaging according to standard of care
* Diagnosis of a metastatic carcinomatous mass in the lung
* Positive study for sleep-disordered breathing (SDB) with intermittent hypoxia (IH) and clinical recommendation for CPAP
* Ability and willingness to undergo baseline and repeat perfusion-CT imaging following 3- to 4 weeks of CPAP therapy for SDB (regardless of CPAP compliance).

Note: Participants will undergo sleep study and receive CPAP therapy as a part of routine care.

Exclusion Criteria

* Lung cancer with a negative sleep study (i.e., no SDB)
* History of radio-contrast allergy
* At excessive risk for contrast nephropathy (following standard radiology renal-risk criteria)
* Pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mark M. Fuster, MD

OTHER

Sponsor Role lead

Responsible Party

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Mark M. Fuster, MD

Associate Professor of Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mark Fuster, MD

Role: PRINCIPAL_INVESTIGATOR

Universityof California, San Diego

Locations

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UC San Diego Moores Cancer Center

La Jolla, California, United States

Site Status

Countries

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United States

Other Identifiers

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161552

Identifier Type: -

Identifier Source: org_study_id