Rehabilitative Approaches: Myofunctional Therapy and Retropalatal Narrowing and Snoring

Snoring Clinical Trial

Official title:

Rehabilitative Approaches: Myofunctional Therapy and Retropalatal Narrowing and Snoring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06186687
• Other study ID #: IKFR-202312.01
• Status: Completed
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: February 28, 2023

Study information

• Verified date: January 2024
• Source: Universitas Padjadjaran
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Sleep is an important activity and snoring is the most often reported complaint. Snoring is also very common in the general population. Moreover, snoring can negatively impact bed companions' quality of sleep, daytime sleepiness, strain of relationships, social embarrassment and disturb mental health that in the end will reduce quality of life. Anatomical risk factors are believed to be one of major contributors to upper airway constriction during sleep. Treatment for this condition include lifestyle modifications (such as quitting alcohol or losing weight), positional therapy, mandibular advancement devices, upper airway surgery, and nasal continuous positive airway pressure. Myofunctional therapy (MT) as an adjunctive or alternative therapy can lower Apnea-Hypopnea Index in obstructive sleep apnea patients with pharyngeal dilator muscle collapse. Although these may be beneficial, the impact of MT on retropalatal narrowing as one of the snoring causes needs to be better established. This study was done to find out the impact of MT in people with snoring who have a collapsed pharynx that is located by a Flexible nasolaryngoscopy.

Description:

Sleep is an important activity; it makes up one-third of a person's life, and in sleep medicine clinics, snoring is the most often reported complaint. Snoring is also very common in the general population. Studies indicate that women have a higher incidence of this condition above 65 years, increasing after menopause, while men experience it between 45 and 64 years of age. While snoring may be a predictor of the more serious condition of obstructive sleep apnea, primary snoring is common. Moreover, snoring can negatively impact bed companions' quality of sleep, daytime sleepiness, strain of relationships, social embarrassment and disturb mental health that in the end will reduce quality of life. Anatomical risk factors are believed to be one of major contributors to upper airway constriction during sleep. Pharyngeal narrowing can be facilitated by anatomic characteristics such as a large neck circumference, soft tissue, bone, or arteries. Flexible nasolaryngoscopy (FN) is an alternative diagnosis to direct viewing of the airway, from the nasal cavity to the larynx area. Aside from being easier to perform and more affordable, a complete examination of the airway can identify the location of the pharyngeal narrowing that causes obstruction more specifically. Treatment for this condition include lifestyle modifications (such as quitting alcohol or losing weight), positional therapy, mandibular advancement devices, upper airway surgery, and nasal continuous positive airway pressure are among the treatments for treating snoring. Myofunctional therapy (MT) as an adjunctive or alternative therapy can lower Apnea-Hypopnea Index in obstructive sleep apnea patients with pharyngeal dilator muscle collapse. The exercises are non-invasive, cost-effective, and have physiological characteristics. Improvement in upper airway obstruction is supported by improvements in upper airway muscle tone. Although these may be beneficial, the impact of MT on retropalatal narrowing as one of the snoring causes needs to be better established. This study was done to find out the impact of MT in people with snoring who have a collapsed pharynx that is located by a FN.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• high risk of OSA (STOP-Bang questionnaire = 3 and Berlin Questionnaire score positive in = 2 category)
• Already diagnosed by an Ear, Nose and Throat specialist as having risk of obstructive sleep apnea based on the questionnaire and FN study that showed pharyngeal muscle collapse in the pharyngeal area (velopharyngeal area/retropalatal)

Exclusion Criteria:

• history of lung disease,
• craniofacial anatomy abnormalities,
• consuming drugs with sedative effects, alcohol, anti-depressants, or anti-anxiety groups in the last 3 months before

Related Conditions & MeSH terms

• Shock
• Snoring

Intervention

Behavioral:
• Myofunctional therapy exercise
Myofunctional therapy involves various exercises to train muscles in the soft palate, tongue, face, and pharynx. Vocal letters are used to train the palatopharyngeus, palatoglossus, uvula, tensor veli palatine, and levator veli palatine muscles. Tongue exercises involve sliding the tongue to the upper and side surfaces of the teeth, placing the tip in front of the palate, and pressing and sucking the tongue up to the palate. Face exercises involve inflating the cheeks, gargling, and sucking the cheeks to exercise the orbicularis oris muscle and the buccinator muscle. Icing stimulates the mouth, producing a cold, chilling, and numbing effect, causing reflexive contraction of the palate, tongue, and pharyngeal muscles.

Locations

Country	Name	City	State
Indonesia	Hasan Sadikin General Hospital	Bandung	Jawa Barat

Sponsors (1)

Lead Sponsor	Collaborator
Universitas Padjadjaran

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Widening of retropalatal area	The retropalatal area was evaluated with flexible nasolaryngoscopy before and after 6 weeks of myofunctional therapy exercise.	6 weeks
Primary	Symptoms of daytime sleepiness	Symptoms of daytime sleepiness was evaluated with Epworth Sleepiness Scale (ESS) score before and after 6 weeks of myofunctional therapy exercise. The minimum values of the socre is 0 and the maximum value is 24. The higher the ESS score, the higher their 'daytime sleepiness', which gives a worse outcome.	6 weeks
Primary	Snoring intensity and frequency	Snoring intensity and frequency evaluation were taken from the Berlin questionnaire before and after 6 weeks of myofunctional therapy exercise.	6 weeks