Respiratory Rehabilitation in Obstructive Sleep Apneas

NCT ID: NCT04412941

Last Updated: 2021-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-22
• Study Completion Date: 2021-01-31

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.

Conditions

Sleep Disorder; Sleep Apnea Syndromes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Treatment group

Myofunctional exercises + home oropharyngeal exercises + the rules of sleep hygiene

Group Type: EXPERIMENTAL

Myofunctional exercises

Intervention Type: BEHAVIORAL

Myofunctional exercises: 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.

Home oropharyngeal exercises: 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.

The rules of sleep hygiene: a list of behaviours that physiologically promote a good night's sleep.

The rules of sleep hygiene

Intervention Type: BEHAVIORAL

The rules of sleep hygiene: a list of behaviours that physiologically promote a good night's sleep.

Control group

the rules of sleep hygiene

Group Type: ACTIVE_COMPARATOR

The rules of sleep hygiene

Intervention Type: BEHAVIORAL

The rules of sleep hygiene: a list of behaviours that physiologically promote a good night's sleep.

Interventions

Myofunctional exercises

Myofunctional exercises: 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.

Home oropharyngeal exercises: 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.

The rules of sleep hygiene: a list of behaviours that physiologically promote a good night's sleep.

Intervention Type: BEHAVIORAL

The rules of sleep hygiene

The rules of sleep hygiene: a list of behaviours that physiologically promote a good night's sleep.

Intervention Type: BEHAVIORAL

Other Intervention Names

home oropharyngeal exercises; the rules of sleep hygiene

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

S. Spirito Hospital, Pescara, Italy

UNKNOWN

Sponsor Role: collaborator

Università degli Studi 'G. d'Annunzio' Chieti e Pescara

OTHER

Sponsor Role: lead

Responsible Party

Paolucci Teresa

Principal Investigator; Research fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Teresa Paolucci, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University G.d'annunzio - Chieti Pescara

Locations

Teresa Paolucci

Chieti, Abruzzo, Italy

Countries

Italy

Other Identifiers

1837-28.06.2019

Identifier Type: -

Identifier Source: org_study_id