NCT01228695

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 26, 2010

Completed
Last Updated

October 26, 2010

Status Verified

February 1, 2010

Enrollment Period

3 years

First QC Date

October 21, 2010

Last Update Submit

October 25, 2010

Conditions

Sleep Apnea

Keywords

steroidspatients treated with systemic steroids

Outcome Measures

Primary Outcomes (1)

  • apnea-hypopnea index

    3 months

Secondary Outcomes (1)

  • sleep study variables

    3 months

Study Arms (1)

steroid treatment

Other: sleep study

Interventions

sleep studyOTHER

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

Also known as: no other names
steroid treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam health care campus

Haifa, 31096, Israel

Location

Related 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. doi: 10.1081/jas-120023577.

    PMID: 14736085BACKGROUND

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 21, 2010

First Posted

October 26, 2010

Study Start

January 1, 2007

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

October 26, 2010

Record last verified: 2010-02

Locations

IL(1)