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Prospective Study of the Impact of Systemic Corticosteroid Use on Measures of Sleep Disordered Breathing

NCT ID: NCT01228695

Last Updated: 2010-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2010-01-31

Brief Summary

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Weight gain is both a significant risk factor for obstructive sleep apnea and a side-effect of long-term systemic steroids therapy.

This study aimed to investigate the impact of long-term systemic steroid treatment on sleep apnea.

Detailed Description

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Conditions

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Sleep Apnea

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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steroid treatment

sleep study

Intervention Type OTHER

The polysomnography (PSG) (Alice 3 System; Healthdyne, Atlanta, GA) consisted of continuous polygraphic recording from surface leads for electroencephalography, electrooculography, electromyography, electrocardiography, thermistors for nasal and oral airflow, thoracic and abdominal impedance belts for respiratory effort, pulse oximeter for oxyhemoglobin level, tracheal microphone for snoring, and sensors for leg and sleep position

Interventions

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sleep study

The polysomnography (PSG) (Alice 3 System; Healthdyne, Atlanta, GA) consisted of continuous polygraphic recording from surface leads for electroencephalography, electrooculography, electromyography, electrocardiography, thermistors for nasal and oral airflow, thoracic and abdominal impedance belts for respiratory effort, pulse oximeter for oxyhemoglobin level, tracheal microphone for snoring, and sensors for leg and sleep position

Intervention Type OTHER

Other Intervention Names

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no other names

Eligibility Criteria

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Inclusion Criteria

* For inclusion, a scheduled therapy with a minimum daily dose of 10 mg prednisone (or equivalent) for at least 3 months was required

Exclusion Criteria

* Patients younger than 18 years and those with known sleep apnea or other forms of sleep-disordered breathing were excluded
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Israeli association for lung disease

UNKNOWN

Sponsor Role collaborator

Rambam Health Care Campus

OTHER

Sponsor Role lead

Locations

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Rambam health care campus

Haifa, , Israel

Site Status

Countries

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Israel

References

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Yigla M, Tov N, Solomonov A, Rubin AH, Harlev D. Difficult-to-control asthma and obstructive sleep apnea. J Asthma. 2003 Dec;40(8):865-71. doi: 10.1081/jas-120023577.

Reference Type BACKGROUND
PMID: 14736085 (View on PubMed)

Other Identifiers

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IRB2421CTIL

Identifier Type: -

Identifier Source: org_study_id