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Behavioral Intervention

Breathing Training for Sleep Apnea

Q: How many participants have been recruited to take part in this investigation?

Affirmative. The clinical trial details found on the website indicate that it is currently recruiting patients, having been published in August 2021 and most recently updated in April 2022. It aims to enroll 122 individuals from a single medical site.

Q: Am I qualified to join this medical experiment?

This clinical research is seeking 122 individuals aged 50 to 80 with <a href="https://www.withpower.com/clinical-trials/hypertension">hypertension</a>. Criteria which must be met in order for patients to qualify include: the capacity to understand and adhere to trial procedures, providing informed consent, accepting random assignment of conditions, an apnea-hypopnea index (AHI) of 15 or higher, unwillingness or inability to comply with continuous positive airway pressure (CPAP), adherence each night when using a mandibular advancement device; systolic blood pressure over 120 mmHg; body mass index below 40 kg/m2; and CPAP compliance - 4 hours per night during 70% of nights within

Q: Are there any vacancies in this clinical research project?

According to clinicaltrials.gov, this research protocol is currently accepting participants. Launched in August 2021 and last edited eight months later, the study has been open for recruitment since its inception date.

Q: Does this trial have an age limit, and if so, what is it?

The minimum age for entry into this trial is 50 years and the maximum is 80, as specified by the selection criteria.

N/A

Recruiting

Led By Elizabeth F Bailey, PhD

Research Sponsored by University of Arizona

Eligibility Criteria Checklist

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

Must have

Ability to understand study procedures and to comply with them for the entire length of the study

Age 50 and older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured at baseline, week 24, week 28, and week 36 to establish the intermediate and long-lasting effects of imst

Awards & highlights

Study Summary

This trial will study whether respiratory strength training can help improve blood pressure and cardiovascular health in adults 50+ with moderate or severe obstructive sleep apnea.

Who is the study for?

Adults aged 50+ with moderate to severe obstructive sleep apnea, who don't use CPAP or are adherent to alternative treatments like mandibular devices. Participants should have stable weight and medication regimens, no recent drug abuse, and be free from unstable diseases. They must have a BMI ≤40 kg/m^2, blood pressure ≥120/≤160 mmHg, cholesterol <240 mg/dL, fasting glucose <300 mg/dL.Check my eligibility

What is being tested?

The trial is testing Inspiratory Muscle Strength Training (IMST) to see if it can improve blood pressure and cardiovascular health in older adults with obstructive sleep apnea. Participants will be randomly assigned to either undergo IMST or not as part of the study.See study design

What are the potential side effects?

While specific side effects of IMST aren't detailed here, potential risks may include discomfort during training exercises or fatigue due to increased respiratory effort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I understand and can follow the study's procedures.

Select...

I am 50 years old or older.

Select...

My weight has been stable for the last 3 months and I can keep it stable during the study.

Select...

I cannot or will not use CPAP for my condition.

Select...

I use my CPAP machine regularly, at least 4 hours a night.

Select...

I use my CPAP machine regularly, at least 4 hours a night for most nights.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at baseline, week 24, week 28, and week 36 to establish the intermediate and long-lasting effects of imst

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured at baseline, week 24, week 28, and week 36 to establish the intermediate and long-lasting effects of imst

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at baseline, week 24, week 28, and week 36 to establish the intermediate and long-lasting effects of imst for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change from baseline casual Systolic Blood Pressure at 24 weeks, 28 weeks, and 36 weeks

Secondary outcome measures

Change from baseline 24-hour Ambulatory Systolic Blood Pressure at 24 weeks, 28 weeks, and 36 weeks

Change from baseline Plasma Norepinephrine at 24 weeks, 28 weeks, and 36 weeks

Other outcome measures

Change from Baseline 24-hour Ambulatory Diastolic Blood Pressure at 24 weeks, 28 weeks, and 36 weeks

Diastolic blood pressure

Change from Baseline Grip Strength at 24 weeks, 28 weeks, and 36 weeks

+10 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Training Group AExperimental Treatment1 Intervention

Participants will perform their respiratory training (high-intensity, low-volume IMST) on a hand-held respiratory training device.

Group II: Training Group BPlacebo Group1 Intervention

Participants will perform their respiratory training (low-intensity, low-volume IMST) on a hand-held respiratory training device.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Inspiratory Muscle Strength Training

2013

N/A

~40

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH

1,675 Previous Clinical Trials

28,020,763 Total Patients Enrolled

University of ArizonaLead Sponsor

514 Previous Clinical Trials

148,472 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,701 Previous Clinical Trials

7,506,728 Total Patients Enrolled

Media Library

Inspiratory Muscle Strength Training (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04932447 — N/A

Obstructive Sleep Apnea Research Study Groups: Training Group A, Training Group B

Obstructive Sleep Apnea Clinical Trial 2023: Inspiratory Muscle Strength Training Highlights & Side Effects. Trial Name: NCT04932447 — N/A

Inspiratory Muscle Strength Training (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04932447 — N/A

Frequently Asked Questions

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

How many participants have been recruited to take part in this investigation?

"Affirmative. The clinical trial details found on the website indicate that it is currently recruiting patients, having been published in August 2021 and most recently updated in April 2022. It aims to enroll 122 individuals from a single medical site."

Answered by AI

Am I qualified to join this medical experiment?

"This clinical research is seeking 122 individuals aged 50 to 80 with hypertension. Criteria which must be met in order for patients to qualify include: the capacity to understand and adhere to trial procedures, providing informed consent, accepting random assignment of conditions, an apnea-hypopnea index (AHI) of 15 or higher, unwillingness or inability to comply with continuous positive airway pressure (CPAP), adherence each night when using a mandibular advancement device; systolic blood pressure over 120 mmHg; body mass index below 40 kg/m2; and CPAP compliance - 4 hours per night during 70% of nights within"

Answered by AI

Are there any vacancies in this clinical research project?

"According to clinicaltrials.gov, this research protocol is currently accepting participants. Launched in August 2021 and last edited eight months later, the study has been open for recruitment since its inception date."

Answered by AI