Sleep ApneaNCT01228695
Prospective Study of the Impact of Systemic Corticosteroid Use on Measures of Sleep Disordered Breathing
An observational study of Sleep Apnea, run by Rambam Health Care Campus at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- sleep study
- Type of treatment
- Pill or oral medicine
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2007to Jan 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients scheduled for long-term treatment with oral prednisone (> 10 mg/d for 3 months or more)
Who may be able to join
- For inclusion, a scheduled therapy with a minimum daily dose of 10 mg prednisone (or equivalent) for at least 3 months was required
Who cannot join
- Patients younger than 18 years and those with known sleep apnea or other forms of sleep-disordered breathing were excluded
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Sleep Apnea
- Being tested
- sleep study
- Keywords
- steroids, patients treated with systemic steroids
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sleep studyOther
Also called no other names
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
| Study group | Role | What they receive |
|---|---|---|
| steroid treatment | Not described Receives: Other: sleep study |
What is being measured
The primary outcome is the main question the study is designed to answer.
apnea-hypopnea index
Measured: 3 months
Secondary outcomes (1)
sleep study variables
apnea-hypopnea interval desaturation at the end of apnea interval snoring intensity
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2010 (estimated)
- Study startJan 2007
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Collaborators
- Israeli association for lung disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01228695
- Sponsor's protocol ID
- IRB2421CTIL
- Status last verified
- Feb 2010
- First submitted
- 21 Oct 2010
- Last updated
- 26 Oct 2010
- Results posted
- No
Publications
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.
PubMed 14736085
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of the Impact of Systemic Corticosteroid Use on Measures of Sleep Disordered Breathing
- ClinicalTrials.gov ID
- NCT01228695
- Acronym / sponsor ID
- IRB2421CTIL
- Conditions
- Sleep Apnea
- Keywords
- steroids, patients treated with systemic steroids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Collaborators
- Israeli association for lung disease
- Study start
- Jan 2007
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 26 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| steroid treatment | – | Other: sleep study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients scheduled for long-term treatment with oral prednisone (> 10 mg/d for 3 months or more)
Key inclusion criteria (1 listed)
- For inclusion, a scheduled therapy with a minimum daily dose of 10 mg prednisone (or equivalent) for at least 3 months was required
Key exclusion criteria (1 listed)
- Patients younger than 18 years and those with known sleep apnea or other forms of sleep-disordered breathing were excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sleep studyAlso: no other namesThe 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 | steroid treatment |
Primary outcome
apnea-hypopnea index
Time frame: 3 months
1 secondary outcome
sleep study variables
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2010.
- Background: PubMed 14736085Yigla 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea, run by Rambam Health Care Campus at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
apnea-hypopnea index (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01228695, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2010.