Supplemental Oxygen for Obstructive Sleep Apnea

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Obstructive Sleep Apnea+4 MoreSupplemental Oxygen - Other
Eligibility
21 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study people with Obstructive Sleep Apnea to try and understand why some people have it and how it affects them.

Eligible Conditions
  • Obstructive Sleep Apnea
  • Sleep Apnea
  • Sleep Disorders
  • Sleep

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 14 Secondary · Reporting Duration: 8 weeks

8 weeks
Beck Depression Index-II
Brief Pain Inventory (Short Form)
Diastolic Blood Pressure
Endothelial Dysfunction
Epworth Sleepiness Scale (ESS)
Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F)
Insomnia Severity Index (ISI)
Neurocognitive Assessment: NIH Toolbox
PROMIS (Patient-Reported Outcomes Measurement Information System) pain intensity
PROMIS (Patient-Reported Outcomes Measurement Information System) pain interference
Patient's Assessment of Own Function Inventory (PAOF) questionnaire
Pittsburgh Sleep Quality Index (PSQI)
Psychomotor Vigilance Test
Richard's Campbell Sleep Questionnaire (RCSQ)
SF-36 Item Health Survey (SF-36)
Systolic Blood Pressure

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Usual PAP Start
1 of 2
Early PAP Start
1 of 2

Experimental Treatment

200 Total Participants · 2 Treatment Groups

Primary Treatment: Supplemental Oxygen · No Placebo Group · Phase 2

Usual PAP StartExperimental Group · 2 Interventions: Supplemental Oxygen, Eszopiclone · Intervention Types: Other, Drug
Early PAP StartExperimental Group · 3 Interventions: Supplemental Oxygen, Continuous Positive Airway Pressure (CPAP), Eszopiclone · Intervention Types: Other, Device, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Continuous Positive Airway Pressure (CPAP)
2004
Completed Phase 3
~2790
Eszopiclone
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 8 weeks

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,028 Previous Clinical Trials
1,805,821 Total Patients Enrolled
Christopher SchmicklPrincipal InvestigatorPostdoc Fellow, Medicine
Atul Malhotra, MDPrincipal InvestigatorProfessor, Medicine
11 Previous Clinical Trials
765 Total Patients Enrolled

Eligibility Criteria

Age 21 - 65 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are at least 21 years old.

Who else is applying?

How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%