Respiratory Rehabilitation in Obstructive Sleep Apneas

NCT04412941 | Completed DMC

• 1 other identifier: 1837-28.06.2019
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disorder; Sleep Apnea Syndromes

Keywords

Rehabilitation; sleep obstructive apnea; oropharyngeal exercises; myofunctional exercises

Outcome Measures

Primary Outcomes (4)

• Change From Baseline in apnea/hypopnea index (AHI)

  AHI is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep.

  4 months

• Sleep questionnaires, Berlin Questionnaire

  it consists of 3 categories related to the risk of sleep apnea (1-severity of snoring, 2- excessive daytime sleepiness, 3-history of obesity or high blood pressure). Depending on the answers and therefore the reported symptoms, it allows a subdivision in high risk or low risk of having apneas;

  4 months

• Sleep questionnaires, Epworth Sleepiness Scale

  it is a scale intended to measure daytime sleepiness with a short questionnaire; the answers range from normal (0) to intense (3) in eight different situations; a total score greater than 10 is considered excessive daytime sleepiness

  4 months

• Sleep questionnaires, Pittsburgh Sleep Quality Index

  It is a self-administered questionnaire that assesses sleep quality over a 1-month time interval. Evaluate seven sleep items on a scale of 0 to 3, 0 indicating no difficulty and 3 indicating severe difficulty. The results are expressed in an overall score (between 0 and 21). Values above 5 are consistent with poor sleep quality.

  4 months

Study Arms (2)

Treatment group

EXPERIMENTAL

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

Behavioral: Myofunctional exercises; Behavioral: The rules of sleep hygiene

Control group

ACTIVE COMPARATOR

the rules of sleep hygiene

Behavioral: The rules of sleep hygiene

Interventions

Myofunctional exercises 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.

Also known as: home oropharyngeal exercises, the rules of sleep hygiene

Treatment group

The rules of sleep hygiene BEHAVIORAL

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

Control group; Treatment group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Università degli Studi 'G. d'Annunzio' Chieti e Pescara: lead
• S. Spirito Hospital, Pescara, Italy: collaborator

Study Sites (1)

Teresa Paolucci

Chieti, Abruzzo, 66100, Italy

Location

MeSH Terms

Conditions

Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias

Study Officials

• Teresa Paolucci, MD, PhD

  University G.d'annunzio - Chieti Pescara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator; Research fellow

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: June 2, 2020
• Study Start: May 22, 2020
• Primary Completion: November 30, 2020
• Study Completion: January 31, 2021
• Last Updated: October 12, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)