Clinical trial NCT05320952: Muscle Strength Exercise and Sleep Apnea
Official title: Effect of Upper Respiratory Muscle Strength Exercise on Sleep Apnea Using WellO2 Respiratory Exercise Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea
Keywords: sleep apnea
muscle strength exercise
WellO2
apnea hypopnea
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
Collaborators: name: WellO2 Oy
name: University of Turku
First posted: 2022-04-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label single group study with three months active phase followed by three months washout.
Primary purpose: TREATMENT

Brief 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.

Detailed description: Research objectives:

1. Will AHI change after 3 months of use of WellO2 (PSG in the beginning and after 3 months)
2. Will the participants get help with fatigue symptoms or quality of life (questionnaires)
3. Is there a response to WellO2 treatment in AHI and symptoms of sleep apnea still after 3 months of WellO2 treatment washout (PSG 3 months after treatment discontinuation)
4. Are the participants able to use the device (questionnaires)

Research design:

A clinical follow-up study in lung clinic sleep apnea patients who are not receiving any other form of sleep apnea treatment. The estimate for the recruitment phase is 6-12 months. The duration of the study is 6 months, of which the active phase with the WellO2 breathing apparatus is 3 months and the washout phase is 3 months after the end of treatment.

Material:

The study enrolled working sleep apnea patients aged 18 to 60 years (n = 50; M: N = 1: 1) with mild to moderate obstructive sleep apnea (AHI 10-29 / h). Exclusion criteria: Previous surgical treatment for sleep apnea, current CPAP or mandibular device therapy, significant history of nasal, oral and pharyngeal disorders, BMI\> 40 kg / m2, other severe pulmonary diseases (eg COPD, asthma, pulmonary fibrosis) severe heart failure (NYHA 3-4), previous brain event, neuromuscular disease or pregnancy, and disability to work.

Methods:

Participants enrolled in the study will be selected from referrals coming to Turku University Hospital for pulmonary department due to sleep apnea. Participants are interviewed in a structured way and demographic and anthropometric data (gender, age, BMI, neck and waist circumference, smoking), sleep apnea symptoms, possible previous treatment attempts, and other known diseases and medications are collected from the interview and from the hospital's patient paper archive. Sleep apnea is examined by sleep polypomyography (polysomnography, PSG) at the beginning of the study, 3 months after WellO2 treatment, and 3 months after the end of treatment. Participants complete the following questionnaires: Epworth Sleepiness Scale (ESS), 12-item General Health Questionnaire (GHQ-12), Depression Survey (DEPS), Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI), Sleep Apnea Symptom Survey, Satisfaction Survey. Measurements of maximal inspiratory pressure (MIP) and maximal expirium pressure (MEP) are used to assess muscle strength, and FEV1, FVC, FEV1 / FVC, and PEF are measured with a miniature spirometer to see the size of the large bronchi and possible bronchial obstruction.

The participant is instructed in the use of the WellO2 orally and in writing. The WellO2 device is used twice a day for 15 minutes at a time at a power corresponding to 30% of the participant's MEP / MIP value. The WellO2 comes with an accessory that records the times and times you have done, as well as the power with the help of a pressure sensor and a mobile assistant. The WellO2 device will continue to be used for a total of 3 months, followed by a second three-month follow-up period without the WellO2 device.

The primary endpoint is resolution of sleep apnea symptoms and PSG findings after 3 months of treatment. The secondary endpoint is whether the effect after 3 months of treatment is maintained after the next 3-month's washout phase.

Significance of the research:

The physiological causes of sleep apnea have been clarified thanks to research in recent years. Hyperbaric ventilator therapy is not suitable for everyone and new therapies are needed for these patients. So far, there is no cure for sleep apnea. The WellO2 breathing training device would be affordable and easy to use for properly targeted sleep apnea patients of all ages.

Eligibility criteria: Inclusion Criteria:

* Age 18-60 years
* Male:Famel 1:1
* AHI 10-29 / h
* working patients

Exclusion Criteria:

* Previous surgical treatment for sleep apnea, current CPAP or mandibular device therapy
* significant history of nasal, oral and pharyngeal disorders
* BMI\> 40 kg / m2
* other severe pulmonary diseases (eg COPD, asthma, pulmonary fibrosis) severe heart failure (NYHA 3-4), previous brain insult, neuromuscular disease or pregnancy, and work disability.

Primary outcomes:
measure: Apnea-hypopnea index, AHI
timeFrame: 3 months
Secondary outcomes:
measure: Sleep apnea symptoms
timeFrame: 3 months
measure: Longterm benefits in AHI and symptoms of sleep apnea
timeFrame: 6 months
measure: WellO2 device usability
timeFrame: 3 months
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital, Division of Medicine, Dept of Pulmonary diseases and University of Turku, Sleep Research Centre
Study officials:
affiliation: Turku University Hospital, Turku, Finland
name: Ulla Anttalainen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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