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Sleep Apnea, ObstructiveNCT03753633

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

A study testing Speech therapy in people with Sleep Apnea, Obstructive and Hypertension Secondary, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 85 years
What is being tested?
Speech therapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 siteBrazil
Study dates
1 Oct 2017to Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Hospital Universitário Clementino Fraga Filho

    Rio de Janeiro, 21941-913

Other trials in Brazil

About this study

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.

Read the detailed description

The database will include demographic characteristics, cardiovascular risk factors and and target-organ damages. Anthropometric measurements (height, weight, and abdominal and neck circumference) will be registered. Daytime sleepiness, quality of sleep and quality of life wiill be evaluated through the respective questionnaires: Epworth sleepiness scale, Pittsburgh Sleep Quality Index (PSQI) and SF-36. In order to evaluate the airway, the Mallampati grade will be used in addition to the adapted assessment protocol from Guimarães (2009). The differences between the final score and the baseline score will be calculated and adjusted by the baseline value found in each of the questionnaires applied. Finally, the analysis excluding the patients with suboptimal adherence to speech therapy treatment (less than 85%) compared to the control group will be redone. If there are benefits of treatment with speech therapy, it will also be offered to the control group after the end of the clinical trial. Statistical analysis will be done in the statistical package SPSS version 19.0 package (SPSS Inc. Chicago, Illinois, USA). Data obtained may be of benefit to future patients and will be used only for statistical purposes. The confidentiality of the information collected will be guaranteed, thus ensuring the privacy and confidentiality of the information. In addition, the data obtained will not be used for other purposes not foreseen in the protocol.

Being tested
Speech therapy, Control
Keywords
speech therapy, sleep apnea, resistant hypertension, quality of life, quality of sleep
Medical subject headings
Sleep Apnea, Obstructive, Communication Disorders, Sleep Apnea Syndromes, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Speech therapyOther

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

  • ControlOther

    Inspiratory and expiratory exercises recruiting diaphragmatic muscles

Study groups in NCT03753633
Study groupRoleWhat they receive
Speech therapy GroupExperimental25 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.
Receives: Other: Speech therapy
Control GroupSham comparator25 patients will perform inspiratory and expiratory exercises recruiting diaphragmatic muscle.
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Five months

  2. 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.

    Measured: Five months

  3. 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.

    Measured: Five months

Secondary outcomes (2)

  1. Apnea-hypopnea index

    The patients were submitted to polysomnography using BrainNet BNT Polipolygraph, supervised by a qualified professional. Electroencephalogram, electrooculogram, submental electromyogram, nasal airflow, oximetry, respiratory effort, electrocardiogram and anterior tibial electromyogram were realized. The exam was complemented with video monitoring. Patients who had less than 240 minutes of sleep in the night were excluded.The report was prepared by a qualified medical professional, Sleep Medicine specialist and with a practice certificate in the area, who was unaware of the patients; clinical data, according to the norms established in the American Academy of Sleep Medicine manual.

    Measured: Three months after Clinical evaluation initial

  2. Qualitative assessment of Speech Therapy Assessment

    Changes in Orofacial Myofunctional after speech therapy in therapy group and after 12 weeks after the evaluation initial in control group. Data were collected from the oromiofunctional speech-language assessment protocol, with face evaluation (eyes, nostrils, lips, cheeks, jaw, tongue and palate) and functions (breath, chew and speech). The UAW physical status, evaluated through the modified Mallampati classification, checks according to the spatial relationship between the soft palate and the body of tongue with the pharynx posterior wall and the narrowing of veil and hypopharynx( class 1, the entire palatopharyngeal veil and uvula are visualized; class 2, uvula and palatopharyngeal veil arches partially visualized; class 3, uvula or palatopharyngeal veil not visualized; class 4, all soft palate not visualized). The anthropometric measurements: height and weight to calculate BMI, neck circumference(greater than 41 cm - women - and 43 cm - men) and waist circumference.

    Measured: Four months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2018
  2. Study start1 Oct 2017
  3. Primary completionDec 2019 (estimated)
  4. Study completionDec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03753633
Sponsor's protocol ID
62061716.1.0000.5257
Status last verified
Nov 2018
First submitted
26 Jan 2017
Last updated
27 Nov 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • AASM - American Academy of Sleep Medicine, International Classification of Sleep Disorders: diagnostic and coding manual, 2nd ed. Westchester, Ill: American Academy of Sleep Medicine; 2005.

  • Acelajado MC, Calhoun DA. Aldosteronism and resistant hypertension. Int J Hypertens. 2011 Jan 20;2011:837817. doi: 10.4061/2011/837817.

    PubMed 21331160

  • Barnes M, Houston D, Worsnop CJ, Neill AM, Mykytyn IJ, Kay A, Trinder J, Saunders NA, Douglas McEvoy R, Pierce RJ. A randomized controlled trial of continuous positive airway pressure in mild obstructive sleep apnea. Am J Respir Crit Care Med. 2002 Mar 15;165(6):773-80. doi: 10.1164/ajrccm.165.6.2003166.

    PubMed 11897643

  • Berger G, Berger R, Oksenberg A. Progression of snoring and obstructive sleep apnoea: the role of increasing weight and time. Eur Respir J. 2009 Feb;33(2):338-45. doi: 10.1183/09031936.00075408. Epub 2008 Nov 14.

    PubMed 19010989

  • Berry RB, Gamaldo CE, Harding SM et al. The AASM Manual for the Scoring of Sleep and Associated Events: Rules, Terminology and Technical Specifications, Version 2.2. www.aasmnet.org. Darien, Illinois: Am Acad Sleep Med, 2015.

  • Bertolazi AN, Fagondes SC, Hoff LS, Dartora EG, Miozzo IC, de Barba ME, Barreto SS. Validation of the Brazilian Portuguese version of the Pittsburgh Sleep Quality Index. Sleep Med. 2011 Jan;12(1):70-5. doi: 10.1016/j.sleep.2010.04.020. Epub 2010 Dec 9.

    PubMed 21145786

  • Bertolazi AN, Fagondes SC, Hoff LS, Pedro VD, Menna Barreto SS, Johns MW. Portuguese-language version of the Epworth sleepiness scale: validation for use in Brazil. J Bras Pneumol. 2009 Sep;35(9):877-83. doi: 10.1590/s1806-37132009000900009. English, Portuguese.

    PubMed 19820814

  • Bittencourt LRA, Togeiro SMGP, Bagnato MC. Diagnóstico da síndrome da apnéia e hipopnéia obstrutiva do sono. In: Stamm A. ed. Rinologia; 2002. São Paulo: Komedi, 2002: 103-111. Disponível em:<http://www.moreirajr.com.br/revistas.asp?fase=r003&id_materia=1628>

  • Bloch KV, Melo AN, Nogueira AR. [Prevalence of anti-hypertensive treatment adherence in patients with resistant hypertension and validation of three indirect methods for assessing treatment adherence]. Cad Saude Publica. 2008 Dec;24(12):2979-84. doi: 10.1590/s0102-311x2008001200030. Portuguese.

    PubMed 19082292

  • Brown LK. Mild obstructive sleep apnea syndrome should be treated. Pro. J Clin Sleep Med. 2007 Apr 15;3(3):259-62. No abstract available.

    PubMed 17561591

  • Burger RCP, Caixeta EC, Di Ninno CQMS. A relação entre apnéia do sono, ronco e respiração oral. Rev CEFAC 2004; 6(3):266-271. Disponível em: <http://cefac.br/revista/revista63/Artigo%206.pdf>.

  • Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

    PubMed 2748771

  • Calhoun DA, Jones D, Textor S, Goff DC, Murphy TP, Toto RD, White A, Cushman WC, White W, Sica D, Ferdinand K, Giles TD, Falkner B, Carey RM. Resistant hypertension: diagnosis, evaluation, and treatment. A scientific statement from the American Heart Association Professional Education Committee of the Council for High Blood Pressure Research. Hypertension. 2008 Jun;51(6):1403-19. doi: 10.1161/HYPERTENSIONAHA.108.189141. Epub 2008 Apr 7.

    PubMed 18391085

  • Chung F, Abdullah HR, Liao P. STOP-Bang Questionnaire: A Practical Approach to Screen for Obstructive Sleep Apnea. Chest. 2016 Mar;149(3):631-8. doi: 10.1378/chest.15-0903. Epub 2016 Jan 12.

    PubMed 26378880

  • Ciconelli RM. et al. Tradução para o português e validação do questionário genérico de avaliação de qualidade de vida "medical outcome study 36-item shortform health survey (SF-36)". Tese (Doutorado em Reumatologia) - Universidade Federal de São Paulo, São Paulo; 1997. Disponível em: http://www.nutrociencia.com.br/upload_files/ artigos_download/qualidade.pdf.

Questions about this trial

What is this clinical trial studying?

A study testing Speech therapy in people with Sleep Apnea, Obstructive and Hypertension Secondary, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Epworth sleepiness scale (time frame: Five months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03753633, which also lists 62 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2018.

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