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CompletedNCT02088723TESTUpdated Oct 20, 2015

Testing the Elevation as Sleep Apnea Treatment

An interventional study of Head of bed elevation in Sleep Apnea, Obstructive, Sleep Apnea Syndromes and Sleep, sponsored by Pulmonar. Completed at 1 site in Brazil. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-10-20.

Sponsored by Pulmonar · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

Read the 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).

02

Conditions studied

  • Sleep Apnea, Obstructive
  • Sleep Apnea Syndromes
  • Sleep

Keywords

  • Sleep Apnea, Obstructive
  • Sleep Apnea Syndromes
  • Polysomnography
  • Sleep
  • Patient Positioning
03

In context

Apnea

1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.

This study's enrollment of 52 is close to the median of 50 across 965 interventional studies indexed under Apnea.

Browse Apnea studies →

Lead sponsor

This is the only study on the registry with Pulmonar as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
52 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralHead 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

06

What researchers measure

Primary outcomes

  1. Apnea-Hypopnea Index compared by the polysomnography standard versus polysomnography with the elevation of the head of the bed

    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).

    Time frame: The difference between the first exam to the second will be 2 weeks.

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Study locations

1 site
  • PULMONAR
    Criciúma, Santa Catarina 88811-503, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 20, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02088723
Lead sponsor
Pulmonar
Responsible party
Sponsor
First posted
Mar 17, 2014
Start date
Sep 2014
Primary completion
Oct 2015
Completion
Oct 2015
Last update
Oct 20, 2015

Study contacts

Fábio José FB Souza, MD MSc
principal investigator · Pulmonar

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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