Effects of Myofunctional Therapy With an Application in Severe Apnea/Hypopnea Sleep Obstructive Syndrome (MTASSAOS)

NCT04438785 | Completed Results DMC

• 1 other identifier: 90694424
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

• Background and study aims: Obstructive sleep apnea is a potentially serious sleep disorder. It causes breathing to stop and start repeatedly during sleep. There are several types of sleep apnea, the most common of which is obstructive sleep apnea. This type of apnea occurs when an individual's throat muscles intermittently relax and block the airway during sleep. The classic treatment for this disease is based on weight loss, and exercise, and the use of a continuous positive airway pressure (CPAP) machine. Myofunctional therapy (MT) is one of the newest treatments for sleep-disordered breathing. MT is based on daily exercises of the throat muscles in an attempt to strengthen them and facilitate opening of the airway. Who can participate? Patients diagnosed with severe sleep apnea and aged between 18-75 years. What does the study involve? Participants will be randomly allocated to either use of the "AirwayGym" smartphone app or no treatment for 3 months. The AirwayGym app provides instructions on how to perform exercises to strengthen the throat muscles and reminds participants to perform the exercises for 20 min per day. Participants will be assessed monthly at the clinic. What are the possible benefits and risks of participating? Benefits: Curing sleep apnea syndrome. There are no significant risks for participants. Where is the study run from? Hospital Quirónsalud Marbella (Spain) When is the study starting and how long is it expected to run for? October 2018 to January 2021 Who is funding the study? Investigator initiated and funded Who is the main contact? Dr. Carlos O'Connor Reina, coconnor@us.es

Conditions

Obstructive Sleep Apnea-hypopnea Syndrome

Keywords

SEVERE OSAHS; MYOFUNTIONAL THERAPY; M HEALTH APPLICATION; TELEMEDICINE

Outcome Measures

Primary Outcomes (2)

• Apnea Hypopnea Index (AHI)

  Measurement of number of apneas or hypopneas recorded during the study per hour of sleep

  Baseline and three months

• Evaluation of O2 Desaturation Index (ODI)

  The ODI is the number of times per hour of sleep that the blood oxygen level drops by a certain degree from baseline. Any respiratory event during sleep with a 3% drop in blood oxygen levels is counted towards the total. For example, a change from 95% to 92% would be an event that is counted toward the index's total.

  Baseline and three months

Secondary Outcomes (7)

• Evaluation of Iowa Oral Performance Instrument (IOPI) Score

  Baseline and three months

• Iowa Oral Performance Instrument Lip Strength

  Baseline and three months

• Neck Circumference (cm)

  Baseline and three months.

• Waist Circumference (cm)

  Baseline and three months

• Body Mass Index BMI

  Baseline and three months

Study Arms (2)

INTERVENTION (AirwayGym) GROUP

EXPERIMENTAL

Patients newly diagnosed with severe OSAHS should perform muscle upper airway exercises using the AirwayGym app for 20 min a day for 90 days.

Device: The intervention consists of myofunctional therapy (MT) using the AirwayGym app.

CONTROL GROUP

NO INTERVENTION

Patients newly diagnosed with severe OSAHS do no therapy for 90 days.

Interventions

The intervention consists of myofunctional therapy (MT) using the AirwayGym app. DEVICE

Intervention. Patient newly diagnosed with severe OSAHS should perform muscle upper airway exercises using the App AirwayGym 20 minutes a day during 90 days.

INTERVENTION (AirwayGym) GROUP

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18-75 years
• Recently diagnosed with severe sleep apnea and do not have any previous experience or information with this pathology
• Consent signed

You may not qualify if:

• BMI \> 40 kg/m²
• Inability to fill up questionnaires
• Severe drug or alcohol abuse
• Hypnotic medication
• Not controlled coronary disease
• Decompensated Heart failure
• Stroke
• Systemic Disease associated with inflammatory diagnosed entity (arthritis, sarcoidosis, vasculitis, lupus…)
• Neuromuscular disease (like Duchenne)
• Craniofacial deformities.
• Active oncologic process.
• Any antecedents of MT treatment or other treatment for sleep apnea could affect study results of the study (surgery, Mandibular Advancement Device (MAD) or CPAP).
• Severe upper airway obstruction (Complete nose obstruction, Tonsils grade IV/IV )
• Presence of tongue tie (Marchesani protocol) with limitation of tongue movements
• Antecedents or presence of temporomandibular joint disorders

Sponsors & Collaborators

• Quironsalud: lead

Study Sites (2)

Hospital Quironsalud Campo de Gibraltar

Los Barrios, Cadiz, 11379, Spain

Location

Hospital Quironsalud Marbella

Marbella, Malaga, 29603, Spain

Location

Related Publications (9)

• Mendes FA, Marone SA, Duarte BB, Arenas AC. Epidemiologic profile of patients with snoring and obstructive sleep apnea in a university hospital. Int Arch Otorhinolaryngol. 2014 Apr;18(2):142-5. doi: 10.1055/s-0033-1359309. Epub 2014 Feb 28.

  PMID: 25992080 BACKGROUND

• Camacho M, Certal V, Abdullatif J, Zaghi S, Ruoff CM, Capasso R, Kushida CA. Myofunctional Therapy to Treat Obstructive Sleep Apnea: A Systematic Review and Meta-analysis. Sleep. 2015 May 1;38(5):669-75. doi: 10.5665/sleep.4652.

  PMID: 25348130 BACKGROUND

• Korhan I, Gode S, Midilli R, Basoglu OK. The influence of the lateral pharyngeal wall anatomy on snoring and sleep apnoea. J Pak Med Assoc. 2015 Feb;65(2):125-30.

  PMID: 25842544 BACKGROUND

• Isetta V, Torres M, Gonzalez K, Ruiz C, Dalmases M, Embid C, Navajas D, Farre R, Montserrat JM. A New mHealth application to support treatment of sleep apnoea patients. J Telemed Telecare. 2017 Jan;23(1):14-18. doi: 10.1177/1357633X15621848. Epub 2016 Jul 8.

  PMID: 26672606 BACKGROUND

• Camacho M, Robertson M, Abdullatif J, Certal V, Kram YA, Ruoff CM, Brietzke SE, Capasso R. Smartphone apps for snoring. J Laryngol Otol. 2015 Oct;129(10):974-9. doi: 10.1017/S0022215115001978. Epub 2015 Sep 3.

  PMID: 26333720 BACKGROUND

• Iftikhar IH, Bittencourt L, Youngstedt SD, Ayas N, Cistulli P, Schwab R, Durkin MW, Magalang UJ. Comparative efficacy of CPAP, MADs, exercise-training, and dietary weight loss for sleep apnea: a network meta-analysis. Sleep Med. 2017 Feb;30:7-14. doi: 10.1016/j.sleep.2016.06.001. Epub 2016 Jun 28.

  PMID: 28215266 BACKGROUND

• Iftikhar IH, Roland J. Obesity Hypoventilation Syndrome. Clin Chest Med. 2018 Jun;39(2):427-436. doi: 10.1016/j.ccm.2018.01.006.

  PMID: 29779600 BACKGROUND

• O'Connor Reina C, Plaza Mayor G, Ignacio-Garcia JM, Baptista Jardin P, Garcia-Iriarte MT, Casado-Morente JC. Floppy Closing Door Epiglottis Treated Successfully with an Mhealth Application Based on Myofunctional Therapy: A Case Report. Case Rep Otolaryngol. 2019 Jul 1;2019:4157898. doi: 10.1155/2019/4157898. eCollection 2019.

  PMID: 31355035 RESULT

• O'Connor-Reina C, Ignacio Garcia JM, Rodriguez Ruiz E, Morillo Dominguez MDC, Ignacio Barrios V, Baptista Jardin P, Casado Morente JC, Garcia Iriarte MT, Plaza G. Myofunctional Therapy App for Severe Apnea-Hypopnea Sleep Obstructive Syndrome: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Nov 9;8(11):e23123. doi: 10.2196/23123.

  PMID: 33093013 RESULT

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

In the end, we had a small sample recruited mainly due to Covid restrictions. We have a significant loss of patients in the control group (50%) due the severity of the disease and the need of therapy. Initially we start to perform polysomnographies but we change to polygraphies due to hospital needs during pandemia.

Results Point of Contact

• Title: Francisco Jesus Gonzalez
• Organization: Grupo Hospitalario Quironsalud

fgonzasan@gmail.com

0034645014593

Study Officials

• JOSE MARIA IGNACIO GARCIA, MD

  NEUMOLOGY DEPARMENT HOSPITAL QUIRONSALUD MARBELLA

  STUDY CHAIR

• FRANCISCO JESUS GONZALEZ SANCHEZPharm D, Pharm D

  RESEARCH UNIT HOSPITAL QUIRONSALUD MARBELLA

  STUDY DIRECTOR

• CARLOS O´CONNOR REINA, MD

  OTOLARINGOLOGY DEPARMENT HOSPITAL QUIRONSALUD MARBELLA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Results will be analysed blinded by the investigators.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional prospective multicentre trial with consecutive random assignment

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 19, 2020
• Study Start: March 1, 2019
• Primary Completion: September 18, 2020
• Study Completion: September 30, 2020
• Last Updated: February 11, 2021
• Results First Posted: January 15, 2021

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)