Cardiovascular DiseasesNCT00005378
Impact of Sleep Disordered Breathing in Older Adults
An observational study of Cardiovascular Diseases and Hypertension, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To test the hypothesis that clinically inapparent sleep-disordered breathing was associated with blood pressure elevation, impairment of health-related quality of life, and depression. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Hypertension, Depression
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jul 1994to May 1998
- 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 Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To test the hypothesis that clinically inapparent sleep-disordered breathing was associated with blood pressure elevation, impairment of health-related quality of life, and depression.
Read the detailed description
BACKGROUND:
The health impact of disordered breathing during sleep among middle-aged and older men and women in the general population had not been well studied, and the need for treating relatively mild degrees of sleep-disordered breathing was unknown in 1994. The study was the first population study which examined the effect of sleep-disordered breathing on these health outcomes. The study sought to establish the prevalence of clinically important sleep-disordered breathing among middle-aged and older men and women and to provide quantitative data to serve as the basis for selecting patients for screening and deciding which patients might benefit from therapeutic intervention.
DESIGN NARRATIVE:
The study evaluated the hypothesis that clinically inapparent sleep-disordered breathing was associated with blood pressure elevation, impairment of health-related quality of life, and depression. The study used the Veterans Administration Normative Aging Study (NAS) population, which consisted of approximately 1,700 community-dwelling-men who returned for examination every three years. Respiratory function was assessed during sleep among these men and their wives using a validated method for home sleep monitoring. Blood pressure, health-related quality of life, and depression score were also assessed in the home. The potential associations of sleep-disordered breathing with hypertension, impaired health-related quality of life, and depression were evaluated, and the possibility that these relationships differed between men and women was examined.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Medical subject headings
- Cardiovascular Diseases, Hypertension, Depression, Sleep Apnea Syndromes, Lung Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startJul 1994
- Study completionMay 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- 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
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005378
- Sponsor's protocol ID
- 4276
- Other IDs
- R01HL051075
- Status last verified
- Nov 2001
- First submitted
- 25 May 2000
- Last updated
- 16 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sleep Disordered Breathing in Older Adults
- ClinicalTrials.gov ID
- NCT00005378
- Acronym / sponsor ID
- 4276
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jul 1994
- Study completion
- May 1998 (actual)
- First posted
- 26 May 2000 (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.
To test the hypothesis that clinically inapparent sleep-disordered breathing was associated with blood pressure elevation, impairment of health-related quality of life, and depression.
Detailed description
BACKGROUND:
The health impact of disordered breathing during sleep among middle-aged and older men and women in the general population had not been well studied, and the need for treating relatively mild degrees of sleep-disordered breathing was unknown in 1994. The study was the first population study which examined the effect of sleep-disordered breathing on these health outcomes. The study sought to establish the prevalence of clinically important sleep-disordered breathing among middle-aged and older men and women and to provide quantitative data to serve as the basis for selecting patients for screening and deciding which patients might benefit from therapeutic intervention.
DESIGN NARRATIVE:
The study evaluated the hypothesis that clinically inapparent sleep-disordered breathing was associated with blood pressure elevation, impairment of health-related quality of life, and depression. The study used the Veterans Administration Normative Aging Study (NAS) population, which consisted of approximately 1,700 community-dwelling-men who returned for examination every three years. Respiratory function was assessed during sleep among these men and their wives using a validated method for home sleep monitoring. Blood pressure, health-related quality of life, and depression score were also assessed in the home. The potential associations of sleep-disordered breathing with hypertension, impaired health-related quality of life, and depression were evaluated, and the possibility that these relationships differed between men and women was examined.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 16 Mar 2016.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Hypertension, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
Where can I read the original study information?
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 16 Mar 2016.