Efficiency of Speech Therapy in Resistant Hypertensive Patients With Mild Obstructive Sleep Apnea Syndrome

NCT03753633 | Unknown DMC

• 1 other identifier: 62061716.1.0000.5257
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to analyze the effect of speech therapy on quality of life, sleep quality, daytime sleepiness level and apnea-hypopnea index in patients with hypertensive patients with mild obstructive apnea syndrome.

Conditions

Sleep Apnea, Obstructive; Hypertension Secondary

Keywords

speech therapy; sleep apnea; resistant hypertension; quality of life; quality of sleep

Outcome Measures

Primary Outcomes (3)

• Changes in Epworth sleepiness scale

  Changes found in score after 12 weeks in control group and speech therapy group. The ESS measures EDS levels, assigning a score (from 0 to 3) according to the possibility of sleeping in each mentioned situation. A score from 0 to 6 is considered normal; from 7 to 9, limitrophe; 10 to 14, mild sleepiness; 15 to 20, moderate sleepiness; and above, severe sleepiness. Values ≥11 are generally associated with sleep disorders.

  Five months

• Changes in SF-36

  Changes found in score after 12 weeks in control group and speech therapy group. The SF-36 consisting of 36 items grouped into eight domains: functional capacity, physical aspects, pain, general health status, vitality, social aspects, emotional aspects and mental health. It assesses both negative (illness or disease) and positive aspects (well-being), with a score from 0 to 100, with zero being the worst health condition and 100 being the best, with each dimension being analyzed separately.

  Five months

• Changes in Pittsburgh Sleep Quality Index (PSQI)

  Changes found in score after 12 weeks in control group and speech therapy group. O questionário de Pittsburgh permite avaliar o sono de forma qualitativa e quantitativa, de forma padronizada, ao determinar os "bons dormidores" e "maus dormidores". O questionário avalia parâmetros quantitativos, tais como a duração do sono, latência do sono e número de despertares; e parâmetros qualitativos, que são puramente subjetivos.

  Five months

Secondary Outcomes (2)

• Apnea-hypopnea index

  Three months after Clinical evaluation initial

• Qualitative assessment of Speech Therapy Assessment

  Four months

Study Arms (2)

Speech therapy Group

EXPERIMENTAL

25 patients will be treated with speech therapy, once a week, during 40 minutes for 12 weeks. Oropharyngeal exercises will be performed under the supervision of a speech therapist. Patients will perform the oropharyngeal exercises at home every day.

Other: Speech therapy

Control Group

SHAM COMPARATOR

25 patients will perform inspiratory and expiratory exercises recruiting diaphragmatic muscle.

Other: Control

Interventions

Speech therapy OTHER

Oropharyngeal exercises will be performed under the supervision of a speech therapist.

Speech therapy Group

Control OTHER

Inspiratory and expiratory exercises recruiting diaphragmatic muscles

Control Group

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients in follow-up in the Hypertension Program (ProHart) at Hospital Universitário Clementino Fraga Filho - UFRJ at least six months;
• Patient with Resistant Hypertension and Mild Obstructive Sleep Apnea detected by polysomnography;
• All participants that give written informed consent.

You may not qualify if:

• Age\> 85 years;
• Cognitive deficit that prevents speech therapy;
• Severe clinical events in the last 6 months;
• Refusal of the patient to participate in the study;
• Pregnancy;
• Prior and regular use of CPAP;
• Clinical data suggestive of neurological disease with cognitive and / or motor sequelae, craniofacial malformation, severe upper airway obstruction, Neuromuscular disease, users of hypnotic drugs

Sponsors & Collaborators

• Universidade Federal do Rio de Janeiro: lead

Study Sites (1)

Hospital Universitário Clementino Fraga Filho

Rio de Janeiro, 21941-913, Brazil

Location

Related Publications (62)

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  BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Communication Disorders; Sleep Apnea Syndromes; Sleep Initiation and Maintenance Disorders

Interventions

Speech Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language Disorders; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Alessandra B de Sousa

  Universidade Federal do Rio de Janeiro

  PRINCIPAL INVESTIGATOR

• Mariana P Brendim, Master

  Universidade Federal do Rio de Janeiro

  STUDY CHAIR

• Elizabeth S Muxfeldt

  Universidade Federal do Rio de Janeiro

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master student

Study Record Dates

• First Submitted: January 26, 2017
• First Posted: November 27, 2018
• Study Start: October 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: November 27, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)