Trial record 3 of 944 for:    "Sleep Apnea Syndromes"

Testing the Elevation as Sleep Apnea Treatment (TEST)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2014 by Pulmonar
Sponsor:
Information provided by (Responsible Party):
Pulmonar
ClinicalTrials.gov Identifier:
NCT02088723
First received: March 10, 2014
Last updated: September 14, 2014
Last verified: September 2014
  Purpose

The purpose of this study is to determine if the elevation of the head of the bed in patients with obstructive sleep apnea can decrease the apnea-hypopnea index. First the investigators will do a standard polysomnography and see if the patients are included analysing the criteria like apnea-hypopnea index equal or more than 5. Within 2 weeks the patient will do the second polysomnography but this will be with a elevation of the head of the bed (15 cm of elevation of the bed doing a inclination). Then the investigators will compare the data of apnea-hypopnea index in the standard polysomnography versus the index with the elevation of the head of the bed.


Condition Intervention
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Sleep
Behavioral: Head of bed elevation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Influence of Elevation of the Head of the Bed in Patients With Obstructive Sleep Apnea

Resource links provided by NLM:


Further study details as provided by Pulmonar:

Primary Outcome Measures:
  • Apnea-Hypopnea Index compared by the polysomnography standard versus polysomnography with the elevation of the head of the bed [ Time Frame: The difference between the first exam to the second will be 2 weeks. ] [ Designated as safety issue: Yes ]
    During the polysomnography there are sensors that detect the airflow by cannula pressure and thermistor. WIth those equipment during the all night the patient will be registered and seen if there is absence of flow (apnea) and/or reduction of flow (hypopnea). The apnea and hypopnea index is done by dividing the number of respiratory events by recording time in hours of sleep (events per hour).


Estimated Enrollment: 52
Study Start Date: September 2014
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: head of bed elevation
Compare the apnea hypopnea index with the patient in standard polysomnography and in elevated polysomnography (head of bed elevation)
Behavioral: Head of bed elevation
head of bed elevation elevation the head of the bed with 15 cm (head of bed elevation) and compare the apnea-hypopnea index with the standard polysomnography

Detailed Description:

There are many researches that demonstrate that the position of the patient modified the apnea-hypopnea index(IAH). In supine position the IAH will increase comparing with lateral position during th sleep. However few studies were done with the elevation of the head of the bed.

First the investigators will do a standard polysomnography and see if the patients are included analysing the criteria like apnea-hypopnea index equal or more than 5. Within 2 weeks the patient will do the second polysomnography but this will be with a elevation of the head of the bed (15 cm of elevation of the bed doing a inclination). Then the investigators will compare the data of apnea-hypopnea index in the standard polysomnography versus the index with the elevation of the head of the bed.The main outcome will be to analyze the apnea hypopnea index comparing standard polysomnography (sPSG) with elevated polysomnography (ePSG).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Berlin questionnaire high risk
  • Epworth score > 9
  • Obstructive Sleep Apnea with an index ≥ 5 events/hour on the polysomnography (The American Academy of Sleep Medicine Manual for the Scoring of Sleep and Associated Events: rules,terminology and technical specifications. American Academy of Sleep Medicine, 2012)

Exclusion Criteria:

  • younger than 18 years and older than 80 years
  • BMI more than 40 Kg/m2
  • heart failure
  • renal failure
  • uncontrolled respiratory disease
  • uncontrolled neurological disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02088723

Contacts
Contact: Fábio José FB Souza, MD MSc 554834374088 fsouzapneumo@hotmail.com
Contact: Albino José Souza Filho, MD 554834337681 albino11@terra.com.br

Locations
Brazil
PULMONAR Not yet recruiting
Criciúma, Santa Catarina, Brazil, 88811-503
Contact: Fábio José FB Souza, MD MSc    554834374088    fsouzapneumo@hotmail.com   
Contact: Albino José Souza Filho, MD    554834337681    albino11@terra.com.br   
Principal Investigator: Fábio José FB Souza, MD MSc         
Sponsors and Collaborators
Pulmonar
Investigators
Principal Investigator: Fábio José FB Souza, MD MSc Pulmonar
  More Information

No publications provided

Responsible Party: Pulmonar
ClinicalTrials.gov Identifier: NCT02088723     History of Changes
Other Study ID Numbers: Apnea-PULMONAR-1
Study First Received: March 10, 2014
Last Updated: September 14, 2014
Health Authority: Brazil: Ethics Committee

Keywords provided by Pulmonar:
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Polysomnography
Sleep
Patient Positioning

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Syndrome
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014