CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
WellO2device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05320952
NCT05320952N/ACompleted

Effect of Upper Respiratory Muscle Strength Exercise on Sleep Apnea Using WellO2 Respiratory Exercise Device

Turku University Hospital·interventional·Posted Apr 11, 2022·Updated May 31, 2025

In Brief

A clinical study evaluating WellO2 for Sleep Apnea. Completed, enrolled 60 participants across 1 site.

Detailed Summary

Background: Obstructive sleep apnea is one of our common diseases and up to 80% of patients are estimated to be undiagnosed. Its main risk factors are overweight, age, male gender, menopause, small jaw, sedative medications / drugs and alcohol. The most important treatment for sleep apnea is continuous positive airway pressure (CPAP). However, not all patients adapt or benefit from device therapy, and up to about 60% stop using the device. Underlying sleep apnea are mechanisms other than anatomical factors such as respiratory wake sensitivity, loop gain control function, and upper respiratory tract muscle activation response and efficiency. Depending on which of these mechanisms dominates as the cause of sleep apnea, the patient's phenotype may vary and CPAP device therapy may not be the correct form of treatment for all patients. Therefore, new targeted therapies should be developed. The WellO2 breathing training device performs back-pressure steam breathing training during the inhalation and exhalation phases. WellO2 effectively exercises the power of the inspiratory muscles, increases the inspiratory muscles, reduces the feeling of dyspnea due to exertion, increases the economy of respiration and delays inhalation muscles. It is a drug-free treatment and easy to use. The use of the WellO2 ventilator has not been previously studied in sleep apnea patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSleep Apnea
CountriesFinland

Timeline

N/ACompletedFinished
2023202420252026
First PostedApr 11, 2022
Enrollment StartMay 23, 2022
Primary CompletionAug 31, 2024
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 4.2 years ago

Interventions

WellO2device

The WellO2 breathing training device performs back-pressure steam breathing training during the inhalation and exhalation phases.