Early Diagnosis and Treatment of Sleep Disordered Breathing in Lung Cancer

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Early Diagnosis and Treatment of Sleep Disordered Breathing in Lung Cancer

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Device: CPAP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of lung cancer in one of 2 sub-types: newly diagnosed early-stage tumor 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CPAP therapy<br>CPAP therapy (minimum of 3-4 weeks) | Device: CPAP<br>* CPAP therapy 3-4 weeks<br>* Other names: continuous positive airway pressure;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tumor perfusion | maximum attenuation value (MAV) detected by perfusion-CT imaging | 3-4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction in circulating tumor cells (CTC) |  | 3-4 weeks | 
| Reduction in tumor promoting micro RNA expression |  | 3-4 weeks | 
| Reduction in nocturnal hypoxia |  | 3-4 weeks | 
| Improvement in sleep quality |  | 3-4 weeks | 
| progression-free survival (PFS) |  | 2 years | 
| overall survival (OS) |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lung cancer, non small cell lung cancer, nsclc, small cell lung cancer, sclc, metastic lung mass, sleep disordered breathing, sdb, obstructive sleep apnea