Clinical trial NCT04412941: Respiratory Rehabilitation in Obstructive Sleep Apneas
Official title: Myofascial Technique Combined With Myofunctional Exercises In Mild Obstructive Sleep Apnea-Hypopneas Syndrome: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disorder
Sleep Apnea Syndromes
Keywords: Rehabilitation
sleep obstructive apnea
oropharyngeal exercises
myofunctional exercises
Lead sponsor: Università degli Studi 'G. d'Annunzio' Chieti e Pescara
Sponsor class: OTHER
Collaborators: name: S. Spirito Hospital, Pescara, Italy
First posted: 2020-06-02
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Obstructive Sleep Apnea is characterized by obstruction of the upper airway during sleep (for at least 10 sec), with repeated breathing pauses, accompanied by oxygen desaturation in the blood and by sleep interruption with repeated arousals.

The investigators hypothesized that good sleep hygiene, the execution of respiratory rehabilitation exercises, with specific myofascial exercises on the muscles that are compromised in the Obstructive Sleep Apnea, can improve the patient's clinical outcome and quality of life.

The objective of this study is to evaluate the effect of respiratory rehabilitation with myo-functional exercises in mild obstructive sleep.

Detailed description: Patients: Eligible patients aged between 40 and 80 years old, with BMI \< 30 and with a recent diagnosis of mild Obstructive Sleep Apnea evaluated with home night cardio-respiratory monitoring.

The investigators will exclude patients with one or more of the following conditions: subjects who regularly use hypnoinductive drugs, with craniofacial malformations, who have suffered recent facial trauma, suffering from hypothyroidism, suffering from neuromuscular diseases, with recent strokes, severe obstructive nasal disease, systemic infectious diseases and neoplastic diseases.

Home night cardio-respiratory monitoring: all patients will be evaluated according to international guidelines (AAMS American Academy Sleep Medicine) with an instrument equipped with sensors for detection oral/nasal flow, snoring, chest/abdomen movements, pulse oximetry and heart rate.

Questionnaire: The investigators will employ questionnaires validated in Italy: Snoring frequency (derived from the Berlin questionnaire); subjective daytime sleepiness (Epworth questionnaire); quality of sleep (Pittsburgh sleep quality questionnaire).

Patients will be randomized into two groups randomly with a 1: 1 ratio: group 1 (treated group) or group 2 (control group) for a total of 20 patients per group (according to the sample size calculation reported in the protocol).

The treatment group will be subjected to an integrated rehabilitation protocol, composed of Respiratory rehabilitation exercises with diaphragmatic breathing, thoracic mobilization exercises and manual pompage techniques, followed by manual trigger point therapy techniques, (that were identified by palpation following the guidelines provided by Travell and Simons trigger point manual), the accessory inspiratory muscles like pectoralis minor muscle, scapula elevator muscle, Sternocleidomastoid muscle. The integrated rehabilitation protocol will be 45 minutes, 3 weekly sessions for 4 weeks, for a total of 12 consecutive sessions. Also, at every patient will be taught oropharyngeal exercises to perform at home twice a day (the duration of 15 minutes each session) involving in particular exercises for soft palate, tongue, facial and genio-glosso muscle.

Both in the treated group and the control group will be given a booklet with the rules for proper sleep hygiene because sleep is influenced by our lifestyle and various environmental factors can affect the quality of night sleep.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of mild Obstructive Sleep Apnea (5≤AHI≤14)
* age between 40 and 80 years
* BMI \<30.

Exclusion Criteria:

* regular use of Hypno-inducing drugs,
* severe nasal obstructive disease,
* primary pulmonary pathology,
* craniofacial malformations,
* recent facial traumas,
* hypothyroidism,
* neuromuscular diseases,
* recent stroke,
* systemic infectious diseases,
* neoplastic diseases.

Primary outcomes:
measure: Change From Baseline in apnea/hypopnea index (AHI)
timeFrame: 4 months
measure: Sleep questionnaires, Berlin Questionnaire
timeFrame: 4 months
measure: Sleep questionnaires, Epworth Sleepiness Scale
timeFrame: 4 months
measure: Sleep questionnaires, Pittsburgh Sleep Quality Index
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chieti
country: Italy
facility: Teresa Paolucci
state: Abruzzo
Study officials:
affiliation: University G.d'annunzio - Chieti Pescara
name: Teresa Paolucci, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: