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CPAP for Obstructive Sleep Apnea (OSAGM Trial)

Q: Is recruitment still open for involvement in this medical experiment?

Affirmative, the clinicaltrials.gov website records that this medical trial is searching for applicants to join their research. This study was first made available on January 17th 2018 and its information was updated most recently on April 11th 2022. Eighty participants are needed from a single site for enrollment in the experiment.

Q: How extensive is the enrollment for this clinical investigation?

Affirmative. Per the data accessible via clinicaltrials.gov, this medical trial has been actively recruiting since 17th January 2018 and was last updated on 11th April 2022. 80 people are required to join from one site only.

Q: Are elderly individuals aged 75 and above eligible for participation in this experimental procedure?

This clinical trial calls for participants between 30-70 years old.

Q: Is there any possibility for me to join this investigation?

This medical trial is seeking out 80 individuals with glucose metabolism abnormalities between the ages of 30 to 70. Additional requirements include a BMI range, body circumference less than 170 cm, no significant weight fluctuations for 3 months prior, untrained status (no regular physical exercise), fasting blood sugar below 126 mg/dl and HbA1c levels lower than 6.5%, AHI rating under 5/h during <a href="https://www.withpower.com/clinical-trials/sleep">sleep</a>, oxygen desaturation index of fewer than 3/hourly readings, absence of known sleep issues or periodic limb movement arousal index ratings below 15 per hour upon polysomnography testing; finally participants must report sleeping at least 6

N/A

Waitlist Available

Led By Bettina Mittendorfer, PhD

Research Sponsored by University of Missouri-Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

OSAGM Trial Summary

This trial will compare glucose metabolism in people with OSA, and those who do not, and by evaluating the effect of treating OSA by providing continuous positive airway pressure (CPAP) or simply oxygen during the night.

Who is the study for?

Adults aged 30-70 with moderate to severe obstructive sleep apnea (OSA), a body mass index between 30 and 45, or body fat over 30% for women and over 25% for men. Participants should not be doing structured exercise more than once a week, have stable weight, no diabetes, and maintain regular sleep schedules. Those with certain diseases, substance use affecting metabolism or sleep, or metal implants incompatible with MRI cannot join.Check my eligibility

What is being tested?

The study is testing how well continuous positive airway pressure (CPAP) or just oxygen at night can improve glucose metabolism in people with OSA compared to a sham treatment. It aims to identify whether disrupted sleep or lack of oxygen affects the body's handling of glucose.See study design

What are the potential side effects?

While CPAP is generally safe, it may cause discomfort like nasal congestion, dry mouth, skin irritation from the mask strap; supplemental oxygen has few side effects but might lead to dryness in throat/nose.

OSAGM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Insulin mediated glucose disposal

Secondary outcome measures

Body composition analysis

Tissue oxygenation

β-cell function

OSAGM Trial Design

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Supplemental Oxygen (O2)Experimental Treatment1 Intervention

Subjects randomized to night-time supplemental oxygen will complete an overnight oxygen titration protocol in the clinical research unit. Initially, subjects will receive 0.5 liters oxygen (O2)/min; the delivery rate will then be increased by 0.5 l/min until oxygen saturation (SaO2) is ≥88%. The optimal O2 delivery rate determined during this study will be used for the intervention. The oxygen concentrators used at home will record cumulative hours of use to provide an objective measure of adherence (monitored weekly). Compliance will be defined as ≥6 h average use per night..

Group II: Positive Airway Pressure (PAP)Experimental Treatment1 Intervention

A registered polysomnographic technologist will perform a titration starting at 4 cm water (H2O) and adjust this value as needed to identify the optimal pressure to achieve an Apnea Hypopnea Index (AHI) <5 (including rapid eye movement sleep in the supine position). After PAP titration, subjects will be instructed to use the machine at the optimal pressure every night for 3 months. Compliance will be defined as: ≥4 hours use on 70% of nights and average use ≥6 hours per night.

Group III: ControlsActive Control1 Intervention

Subjects without OSA will be recruited and complete all testing for primary outcome measures, but will not undergo any intervention.

Group IV: ShamPlacebo Group1 Intervention

Subjects in the sham treatment group will complete the oxygen titration protocol described for the night-time supplemental oxygen group, except that their oxygen concentrator will have been covertly modified to deliver room air at a rate of 0.5 l/min.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Positive Airway Pressure

2009

N/A

~490

Supplemental Oxygen

2004

Completed Phase 3

~370

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Missouri-ColumbiaLead Sponsor

361 Previous Clinical Trials

627,914 Total Patients Enrolled

1 Trials studying Sleep Apnea

54 Patients Enrolled for Sleep Apnea

Washington University School of MedicineLead Sponsor

1,930 Previous Clinical Trials

2,298,887 Total Patients Enrolled

Bettina Mittendorfer, PhDPrincipal InvestigatorWashington University School of Medicine

8 Previous Clinical Trials

498 Total Patients Enrolled

Media Library

Positive Airway Pressure Clinical Trial Eligibility Overview. Trial Name: NCT03408613 — N/A

Sleep Apnea Research Study Groups: Supplemental Oxygen (O2), Sham, Positive Airway Pressure (PAP), Controls

Sleep Apnea Clinical Trial 2023: Positive Airway Pressure Highlights & Side Effects. Trial Name: NCT03408613 — N/A

Positive Airway Pressure 2023 Treatment Timeline for Medical Study. Trial Name: NCT03408613 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment still open for involvement in this medical experiment?

"Affirmative, the clinicaltrials.gov website records that this medical trial is searching for applicants to join their research. This study was first made available on January 17th 2018 and its information was updated most recently on April 11th 2022. Eighty participants are needed from a single site for enrollment in the experiment."

Answered by AI

How extensive is the enrollment for this clinical investigation?

"Affirmative. Per the data accessible via clinicaltrials.gov, this medical trial has been actively recruiting since 17th January 2018 and was last updated on 11th April 2022. 80 people are required to join from one site only."

Answered by AI

Are elderly individuals aged 75 and above eligible for participation in this experimental procedure?

"This clinical trial calls for participants between 30-70 years old."

Answered by AI

Is there any possibility for me to join this investigation?

"This medical trial is seeking out 80 individuals with glucose metabolism abnormalities between the ages of 30 to 70. Additional requirements include a BMI range, body circumference less than 170 cm, no significant weight fluctuations for 3 months prior, untrained status (no regular physical exercise), fasting blood sugar below 126 mg/dl and HbA1c levels lower than 6.5%, AHI rating under 5/h during sleep, oxygen desaturation index of fewer than 3/hourly readings, absence of known sleep issues or periodic limb movement arousal index ratings below 15 per hour upon polysomnography testing; finally participants must report sleeping at least 6"

Answered by AI

Who else is applying?

What state do they live in?

Missouri

What site did they apply to?

Washington University School of Medicine

What portion of applicants met pre-screening criteria?

Did not meet criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

I take bp meds 4 x day. My bp is still not under control, fluctuating between 137 and 150 in the morning when I wake up. Extremely sensitive to salt. Bp goes up quickly after a salty food. Working hard on DASH diet. Sleep has be interrupted 2-3 x per night for the bathroom for the past4+ years.

PatientReceived 1 prior treatment