Muscle Strength Exercise and Sleep Apnea

NCT05320952 | Completed

• 1 other identifier: TO5/004/22
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea

Keywords

sleep apnea; muscle strength exercise; WellO2; apnea hypopnea

Outcome Measures

Primary Outcomes (1)

• Apnea-hypopnea index, AHI

  Change in AHI measured from polysomnogaphy in the beginning and after 3 month's of WellO2 treatment?

  3 months

Secondary Outcomes (3)

• Sleep apnea symptoms

  3 months

• Longterm benefits in AHI and symptoms of sleep apnea

  6 months

• WellO2 device usability

  3 months

Study Arms (1)

working sleep apnea patients

EXPERIMENTAL

50 sleep apnea patients with mild to moderate sleep apnea using WellO2 device for three months

Device: WellO2

Interventions

WellO2 DEVICE

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

working sleep apnea patients

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Turku University Hospital: lead
• WellO2 Oy: collaborator
• University of Turku: collaborator

Study Sites (1)

Turku University Hospital, Division of Medicine, Dept of Pulmonary diseases and University of Turku, Sleep Research Centre

Turku, 20520, Finland

Location

Related Publications (10)

• Peppard PE, Young T, Barnet JH, Palta M, Hagen EW, Hla KM. Increased prevalence of sleep-disordered breathing in adults. Am J Epidemiol. 2013 May 1;177(9):1006-14. doi: 10.1093/aje/kws342. Epub 2013 Apr 14.

  PMID: 23589584 BACKGROUND

• Afsharpaiman S, Shahverdi E, Vahedi E, Aqaee H. Continuous Positive Airway Pressure Compliance in Patients with Obstructive Sleep Apnea. Tanaffos. 2016;15(1):25-30.

  PMID: 27403175 BACKGROUND

• Dempsey JA, Xie A, Patz DS, Wang D. Physiology in medicine: obstructive sleep apnea pathogenesis and treatment--considerations beyond airway anatomy. J Appl Physiol (1985). 2014 Jan 1;116(1):3-12. doi: 10.1152/japplphysiol.01054.2013. Epub 2013 Nov 7.

  PMID: 24201709 BACKGROUND

• Eckert DJ. Phenotypic approaches to obstructive sleep apnoea - New pathways for targeted therapy. Sleep Med Rev. 2018 Feb;37:45-59. doi: 10.1016/j.smrv.2016.12.003. Epub 2016 Dec 18.

  PMID: 28110857 BACKGROUND

• Enright SJ, Unnithan VB, Heward C, Withnall L, Davies DH. Effect of high-intensity inspiratory muscle training on lung volumes, diaphragm thickness, and exercise capacity in subjects who are healthy. Phys Ther. 2006 Mar;86(3):345-54.

  PMID: 16506871 BACKGROUND

• Karsten M, Ribeiro GS, Esquivel MS, Matte DL. The effects of inspiratory muscle training with linear workload devices on the sports performance and cardiopulmonary function of athletes: A systematic review and meta-analysis. Phys Ther Sport. 2018 Nov;34:92-104. doi: 10.1016/j.ptsp.2018.09.004. Epub 2018 Sep 15.

  PMID: 30261349 BACKGROUND

• Romer LM, McConnell AK. Specificity and reversibility of inspiratory muscle training. Med Sci Sports Exerc. 2003 Feb;35(2):237-44. doi: 10.1249/01.MSS.0000048642.58419.1E.

  PMID: 12569211 BACKGROUND

• Romer LM, McConnell AK, Jones DA. Effects of inspiratory muscle training on time-trial performance in trained cyclists. J Sports Sci. 2002 Jul;20(7):547-62. doi: 10.1080/026404102760000053.

  PMID: 12166881 BACKGROUND

• Turner LA, Tecklenburg-Lund SL, Chapman RF, Stager JM, Wilhite DP, Mickleborough TD. Inspiratory muscle training lowers the oxygen cost of voluntary hyperpnea. J Appl Physiol (1985). 2012 Jan;112(1):127-34. doi: 10.1152/japplphysiol.00954.2011. Epub 2011 Oct 6.

  PMID: 21979803 BACKGROUND

• Al-Rammahi U, Soukka T, Malinen J, Happonen RP, Sovijarvi A, Anttalainen U. Effects of steam-assisted respiratory muscle training on sleep apnoea symptoms and pulmonary function in men and women: a pilot study. Sleep Breath. 2025 Sep 15;29(5):286. doi: 10.1007/s11325-025-03449-2.

  PMID: 40952626 DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Ulla Anttalainen, MD, PhD

  Turku University Hospital, Turku, Finland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Open label single group study with three months active phase followed by three months washout.

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: April 11, 2022
• Study Start: May 23, 2022
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)