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Respiratory Rehabilitation in Obstructive Sleep Apneas (OSA20)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04412941
Recruitment Status : Enrolling by invitation
First Posted : June 2, 2020
Last Update Posted : July 1, 2020
Sponsor:
Collaborator:
S. Spirito Hospital, Pescara, Italy
Information provided by (Responsible Party):
Paolucci Teresa, Università degli Studi 'G. d'Annunzio' Chieti e Pescara

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.


Condition or disease Intervention/treatment Phase
Sleep Disorder Sleep Apnea Syndromes Behavioral: Myofunctional exercises Behavioral: The rules of sleep hygiene Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Respiratory Rehabilitation With Myo-functional Exercises in Patients With Mild Obstructive Apneas: a Randomized Controlled Trial
Actual Study Start Date : May 22, 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment group
Myofunctional exercises + home oropharyngeal exercises + the rules of sleep hygiene
Behavioral: 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.

Other Names:
  • home oropharyngeal exercises
  • the rules of sleep hygiene

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

Active Comparator: Control group
the rules of sleep hygiene
Behavioral: The rules of sleep hygiene
The rules of sleep hygiene: a list of behaviours that physiologically promote a good night's sleep.




Primary Outcome Measures :
  1. Change From Baseline in apnea/hypopnea index (AHI) [ Time Frame: 4 months ]
    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.

  2. Sleep questionnaires, Berlin Questionnaire [ Time Frame: 4 months ]
    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;

  3. Sleep questionnaires, Epworth Sleepiness Scale [ Time Frame: 4 months ]
    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. Sleep questionnaires, Pittsburgh Sleep Quality Index [ Time Frame: 4 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04412941


Locations
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Italy
Teresa Paolucci
Chieti, Abruzzo, Italy, 66100
Sponsors and Collaborators
Università degli Studi 'G. d'Annunzio' Chieti e Pescara
S. Spirito Hospital, Pescara, Italy
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Responsible Party: Paolucci Teresa, Principal Investigator; Research fellow, Università degli Studi 'G. d'Annunzio' Chieti e Pescara
ClinicalTrials.gov Identifier: NCT04412941    
Other Study ID Numbers: richj9rur
First Posted: June 2, 2020    Key Record Dates
Last Update Posted: July 1, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Paolucci Teresa, Università degli Studi 'G. d'Annunzio' Chieti e Pescara:
Rehabilitation
sleep obstructive apnea
oropharyngeal exercises
myofunctional exercises
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Wake Disorders
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Nervous System Diseases
Neurologic Manifestations
Mental Disorders