Rehabilitative Approaches: Myofunctional Therapy and Retropalatal Narrowing and Snoring

NCT06186687 | Completed DMC

• 1 other identifier: IKFR-202312.01
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Snoring; Pharyngeal Collapse

Keywords

Myofunctional therapy exercise; pharyngeal area collapse; snoring

Outcome Measures

Primary Outcomes (3)

• Widening of retropalatal area

  The retropalatal area was evaluated with flexible nasolaryngoscopy before and after 6 weeks of myofunctional therapy exercise.

  6 weeks

• 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

• 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

Study Arms (1)

Myofunctional Therapy Exercise

EXPERIMENTAL

Seventeen patients whom 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), performed MT two times per day for 20 minutes every day for six weeks. Exercises were performed at home with monitoring by the exercise log book, submitting a clear video of each exercise, and being evaluated once a week by the doctor. Patient compliance was classified as good if the patient performed \>75% of the exercises weekly. This study evaluated the velopharynx/retropalatal area (with FN), symptoms of daytime sleepiness with the Epworth Sleepiness Scale (ESS) questionnaire, and snoring intensity and frequency taken from the Berlin questionnaire that were filled out before and after undergoing training for 6 weeks.

Behavioral: Myofunctional therapy exercise

Interventions

Myofunctional therapy exercise BEHAVIORAL

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.

Myofunctional Therapy Exercise

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitas Padjadjaran: lead

Study Sites (1)

Hasan Sadikin General Hospital

Bandung, West Java, 40161, Indonesia

Location

MeSH Terms

Conditions

Snoring

Condition Hierarchy (Ancestors)

Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Vitriana Biben, Dr; MD

  Faculty of Medicine Universitas Padjadjaran

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: January 2, 2024
• Study Start: September 1, 2022
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: January 5, 2024

Record last verified: 2024-01

Locations

ID (1)