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

This study has been completed.
Sponsor:
Collaborator:
Israeli association for lung disease
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01228695
First received: October 21, 2010
Last updated: October 25, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention
Sleep Apnea
Other: sleep study

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • apnea-hypopnea index [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • sleep study variables [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    apnea-hypopnea interval desaturation at the end of apnea interval snoring intensity


Estimated Enrollment: 20
Study Start Date: January 2007
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
steroid treatment Other: 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
Other Name: no other names

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients scheduled for long-term treatment with oral prednisone (> 10 mg/d for 3 months or more)

Criteria

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
  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: NCT01228695

Locations
Israel
Rambam health care campus
Haifa, Israel, 31096
Sponsors and Collaborators
Rambam Health Care Campus
Israeli association for lung disease
  More Information

Publications:
Responsible Party: Israeli association for lung disease
ClinicalTrials.gov Identifier: NCT01228695     History of Changes
Other Study ID Numbers: IRB2421CTIL
Study First Received: October 21, 2010
Last Updated: October 25, 2010
Health Authority: Israel: Ministry of Health

Keywords provided by Rambam Health Care Campus:
steroids
patients treated with systemic steroids

ClinicalTrials.gov processed this record on October 01, 2014