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

Sleep Apnea Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01228695
• Other study ID #: IRB2421CTIL
• Status: Completed
• Phase: N/A
• First received: October 21, 2010
• Last updated: October 25, 2010
• Start date: January 2007
• Est. completion date: January 2010

Study information

• Verified date: February 2010
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Sleep Apnea

Intervention

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

Locations

Country	Name	City	State
Israel	Rambam health care campus	Haifa

Sponsors (2)

Lead Sponsor	Collaborator
Rambam Health Care Campus	Israeli association for lung disease

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	apnea-hypopnea index		3 months	No
Secondary	sleep study variables	apnea-hypopnea interval desaturation at the end of apnea interval snoring intensity	3 months	No