search
Back to results

Respiratory Rehabilitation in Obstructive Sleep Apneas (OSA20)

Primary Purpose

Sleep Disorder, Sleep Apnea Syndromes

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Myofunctional exercises
The rules of sleep hygiene
Sponsored by
Università degli Studi 'G. d'Annunzio' Chieti e Pescara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disorder focused on measuring Rehabilitation, sleep obstructive apnea, oropharyngeal exercises, myofunctional exercises

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Teresa Paolucci

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment group

Control group

Arm Description

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

the rules of sleep hygiene

Outcomes

Primary Outcome Measures

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.
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;
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
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.

Secondary Outcome Measures

Full Information

First Posted
May 22, 2020
Last Updated
October 4, 2021
Sponsor
Università degli Studi 'G. d'Annunzio' Chieti e Pescara
Collaborators
S. Spirito Hospital, Pescara, Italy
search

1. Study Identification

Unique Protocol Identification Number
NCT04412941
Brief Title
Respiratory Rehabilitation in Obstructive Sleep Apneas
Acronym
OSA20
Official Title
Myofascial Technique Combined With Myofunctional Exercises In Mild Obstructive Sleep Apnea-Hypopneas Syndrome: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
May 22, 2020 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
January 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Università degli Studi 'G. d'Annunzio' Chieti e Pescara
Collaborators
S. Spirito Hospital, Pescara, Italy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorder, Sleep Apnea Syndromes
Keywords
Rehabilitation, sleep obstructive apnea, oropharyngeal exercises, myofunctional exercises

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Myofunctional exercises + home oropharyngeal exercises + the rules of sleep hygiene
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
the rules of sleep hygiene
Intervention Type
Behavioral
Intervention Name(s)
Myofunctional exercises
Other Intervention Name(s)
home oropharyngeal exercises, the rules of sleep hygiene
Intervention Description
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
Intervention Name(s)
The rules of sleep hygiene
Intervention Description
The rules of sleep hygiene: a list of behaviours that physiologically promote a good night's sleep.
Primary Outcome Measure Information:
Title
Change From Baseline in apnea/hypopnea index (AHI)
Description
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.
Time Frame
4 months
Title
Sleep questionnaires, Berlin Questionnaire
Description
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;
Time Frame
4 months
Title
Sleep questionnaires, Epworth Sleepiness Scale
Description
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
Time Frame
4 months
Title
Sleep questionnaires, Pittsburgh Sleep Quality Index
Description
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.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teresa Paolucci, MD, PhD
Organizational Affiliation
University G.d'annunzio - Chieti Pescara
Official's Role
Principal Investigator
Facility Information:
Facility Name
Teresa Paolucci
City
Chieti
State/Province
Abruzzo
ZIP/Postal Code
66100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make IPD available, because we didn't get organized

Learn more about this trial

Respiratory Rehabilitation in Obstructive Sleep Apneas

We'll reach out to this number within 24 hrs