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Procedure

NovaResp MAPR System for Sleep Apnea

N/A

Recruiting

Research Sponsored by NovaResp Technologies Inc

Eligibility Criteria Checklist

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

Must have

Must be between 18 and 70 years old. People over 70 are excluded from this study, as they are more likely to have co-morbidities that overlap with the exclusion criteria for the study.

Must be diagnosed with OSA

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 hours

Awards & highlights

Study Summary

This trial evaluates the potential of using existing CPAP machines to apply air pressure, creating pulses of negative airway pressure & changes in airway pressure, to activate the genioglossus muscle & reduce sleep apnea symptoms.

Who is the study for?

This trial is for adults aged 18-70 with moderate to severe obstructive sleep apnea (OSA), a BMI under 35, and who can follow the study's rules. Participants must understand English, provide consent, and lend their personal PAP device for settings transfer. Excluded are those using bi-level PAP or oxygen therapy, with severe heart conditions or recent strokes, unstable health issues like cancer or dementia, pregnant women, and individuals with certain neuromuscular diseases.Check my eligibility

What is being tested?

The NovaResp MAPR System is being tested as an alternative to conventional CPAP machines for OSA treatment. It aims to activate airway muscles by applying brief air pressure maneuvers during sleep therapy using modified CPAP devices that include this new system.See study design

What are the potential side effects?

While specific side effects of the NovaResp MAPR System aren't detailed here, similar treatments may cause discomfort at the mask site, dry mouth/nose/throat from airflow pressure changes during use.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 70 years old.

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I have been diagnosed with obstructive sleep apnea.

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I have moderate or severe sleep apnea.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 hours for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Evaluating decrease in AHI

Evaluating level of activation through EMG

Trial Design

1Treatment groups

Experimental Treatment

Group I: Muscle ActivationExperimental Treatment1 Intervention

Participants in this arm will receive intervention via application of brief air pressure maneuvers.

0 / 3Eligibility criteria met

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Who is running the clinical trial?

NovaResp Technologies IncLead Sponsor

3 Previous Clinical Trials

265 Total Patients Enrolled

1 Trials studying Sleep Apnea

50 Patients Enrolled for Sleep Apnea

Frequently Asked Questions

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

Is the age limit for acceptance into this experiment greater than 25?

"The inclusion criteria for this medical trial stipulates that only individuals aged 18 or above and 70 or below are eligible to participate."

Answered by AI

Is enrollment for this clinical trial still open?

"According to clinicaltrials.gov, this trial is not presently enrolling participants; the listing was first published on August 1st 2023 and updated less than two weeks ago. However, there are over 200 other trials currently recruiting patients at present."

Answered by AI

Could I potentially be eligible to take part in this research?

"For this particular trial, 10 individuals with sleep apnea aged between 18 and 70 are being sought after. Notably, the applicants must have a Body Mass Index less than 35 kg/m2 and be diagnosed with Obstructive Sleep Apnoea."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Airway Muscle Activation on Sleep-disordered Breathing Events

2023. "Airway Muscle Activation on Sleep-disordered Breathing Events". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06002061.