Lung DiseasesNCT00005297
Age-related Prevalence of Sleep Respiratory Disturbances
An observational study of Lung Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To determine the prevalence and longitudinal course of sleep apnea among men and women and to examine the associations of apnea, oxygen desaturation, snoring, high blood pressure, and other biomedical correlates. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Lung Diseases, Heart Diseases, Hypertension
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Apr 1990to Jun 1997
- 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 determine the prevalence and longitudinal course of sleep apnea among men and women and to examine the associations of apnea, oxygen desaturation, snoring, high blood pressure, and other biomedical correlates.
Read the detailed description
BACKGROUND:
Sleep apnea is characterized by repetitive cessations of respiration during sleep with consequent decreases in arterial oxygen saturation. Sleep apnea can be caused by upper airway obstruction or by central nervous system failure to sufficiently excite the diaphragm and accessory respiratory muscles. However, in most cases, both processes are involved. Hypopneas, in which airflow is significantly compromised without complete cessations of respiratory flow, and snoring are often found in association with apneas. Both apneas and hypopneas cause repetitive disruptions of sleep, consequent daytime somnolence, and complex cardio-respiratory disturbances.
DESIGN NARRATIVE:
The study was longitudinal in design. A stratified random sample of adults in San Diego was used to examine risk factors in the prevalence of sleep respiratory disturbances. A structured random sample was selected by random digit telephone dialing. Subjects were studied in their homes. Some were followed yearly during the project. Each volunteer gave a brief sleep history and medical review, including blood pressure measurement, the National Interview Survey, And Quality of Well-being Scale. Blood oxygen saturation, pulse rate, snoring, and sleep duration were recorded for three nights. State-of-the-art computerized pulse oximeters and microprocessor-based activity/light monitors were used. Subjects found to have the most severe sleep respiratory disturbances underwent laboratory polysomnograms to add descriptive data and to validate the survey methodology. The prevalence of respiratory disturbances in sleep was analyzed as a function of age and sex. Associations with several aspects of morbidity were determined. The longitudinal course of respiratory disturbances in sleep were 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.
- Conditions
- Lung Diseases, Heart Diseases, Hypertension, Sleep Apnea Syndromes
- Medical subject headings
- Lung Diseases, Heart Diseases, Hypertension, Sleep Apnea Syndromes
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 startApr 1990
- Study completionJun 1997
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Lung 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
- Investigators
- Daniel Kripke, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005297
- Sponsor's protocol ID
- 2020
- Other IDs
- R01HL040930
- Status last verified
- Mar 2005
- First submitted
- 25 May 2000
- Last updated
- 29 Feb 2016
- Results posted
- No
Publications
Espiritu RC, Kripke DF, Ancoli-Israel S, Mowen MA, Mason WJ, Fell RL, Klauber MR, Kaplan OJ. Low illumination experienced by San Diego adults: association with atypical depressive symptoms. Biol Psychiatry. 1994 Mar 15;35(6):403-7. doi: 10.1016/0006-3223(94)90007-8.
PubMed 8018787Kripke DF, Ancoli-Israel S, Klauber MR, Wingard DL, Mason WJ, Mullaney DJ. Prevalence of sleep-disordered breathing in ages 40-64 years: a population-based survey. Sleep. 1997 Jan;20(1):65-76. doi: 10.1093/sleep/20.1.65.
PubMed 9130337Ando K, Kripke DF. Light attenuation by the human eyelid. Biol Psychiatry. 1996 Jan 1;39(1):22-5. doi: 10.1016/0006-3223(95)00109-3.
PubMed 8719122Rex KM, Kripke DF, Cole RJ, Klauber MR. Nocturnal light effects on menstrual cycle length. J Altern Complement Med. 1997 Winter;3(4):387-90. doi: 10.1089/acm.1997.3.387.
PubMed 9449059Jean-Louis G, Kripke DF, Ancoli-Israel S, Klauber MR, Sepulveda RS, Mowen MA, Assmus JD, Langer RD. Circadian sleep, illumination, and activity patterns in women: influences of aging and time reference. Physiol Behav. 2000 Jan;68(3):347-52. doi: 10.1016/s0031-9384(99)00186-9.
PubMed 10716544Jean-Louis G, von Gizycki H, Zizi F. Predictors of subjective sleepiness induced by melatonin administration. J Psychosom Res. 1999 Oct;47(4):355-8. doi: 10.1016/s0022-3999(98)00076-2.
PubMed 10616229Jean-Louis G, Mendlowicz MV, Von Gizycki H, Zizi F, Nunes J. Assessment of physical activity and sleep by actigraphy: examination of gender differences. J Womens Health Gend Based Med. 1999 Oct;8(8):1113-7. doi: 10.1089/jwh.1.1999.8.1113.
PubMed 10565670Jean-Louis G, Zizi F, von Gizycki H, Hauri P. Actigraphic assessment of sleep in insomnia: application of the Actigraph Data Analysis Software (ADAS). Physiol Behav. 1999 Jan 1-15;65(4-5):659-63. doi: 10.1016/s0031-9384(98)00213-3.
PubMed 10073464
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age-related Prevalence of Sleep Respiratory Disturbances
- ClinicalTrials.gov ID
- NCT00005297
- Acronym / sponsor ID
- 2020
- Conditions
- Lung Diseases, Heart Diseases, Hypertension, Sleep Apnea Syndromes
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Apr 1990
- Study completion
- Jun 1997 (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 determine the prevalence and longitudinal course of sleep apnea among men and women and to examine the associations of apnea, oxygen desaturation, snoring, high blood pressure, and other biomedical correlates.
Detailed description
BACKGROUND:
Sleep apnea is characterized by repetitive cessations of respiration during sleep with consequent decreases in arterial oxygen saturation. Sleep apnea can be caused by upper airway obstruction or by central nervous system failure to sufficiently excite the diaphragm and accessory respiratory muscles. However, in most cases, both processes are involved. Hypopneas, in which airflow is significantly compromised without complete cessations of respiratory flow, and snoring are often found in association with apneas. Both apneas and hypopneas cause repetitive disruptions of sleep, consequent daytime somnolence, and complex cardio-respiratory disturbances.
DESIGN NARRATIVE:
The study was longitudinal in design. A stratified random sample of adults in San Diego was used to examine risk factors in the prevalence of sleep respiratory disturbances. A structured random sample was selected by random digit telephone dialing. Subjects were studied in their homes. Some were followed yearly during the project. Each volunteer gave a brief sleep history and medical review, including blood pressure measurement, the National Interview Survey, And Quality of Well-being Scale. Blood oxygen saturation, pulse rate, snoring, and sleep duration were recorded for three nights. State-of-the-art computerized pulse oximeters and microprocessor-based activity/light monitors were used. Subjects found to have the most severe sleep respiratory disturbances underwent laboratory polysomnograms to add descriptive data and to validate the survey methodology. The prevalence of respiratory disturbances in sleep was analyzed as a function of age and sex. Associations with several aspects of morbidity were determined. The longitudinal course of respiratory disturbances in sleep were 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 29 Feb 2016.
- Background: PubMed 8018787Espiritu RC, Kripke DF, Ancoli-Israel S, Mowen MA, Mason WJ, Fell RL, Klauber MR, Kaplan OJ. Low illumination experienced by San Diego adults: association with atypical depressive symptoms. Biol Psychiatry. 1994 Mar 15;35(6):403-7. doi: 10.1016/0006-3223(94)90007-8.
- Background: PubMed 9130337Kripke DF, Ancoli-Israel S, Klauber MR, Wingard DL, Mason WJ, Mullaney DJ. Prevalence of sleep-disordered breathing in ages 40-64 years: a population-based survey. Sleep. 1997 Jan;20(1):65-76. doi: 10.1093/sleep/20.1.65.
- Background: PubMed 8719122Ando K, Kripke DF. Light attenuation by the human eyelid. Biol Psychiatry. 1996 Jan 1;39(1):22-5. doi: 10.1016/0006-3223(95)00109-3.
- Background: PubMed 9449059Rex KM, Kripke DF, Cole RJ, Klauber MR. Nocturnal light effects on menstrual cycle length. J Altern Complement Med. 1997 Winter;3(4):387-90. doi: 10.1089/acm.1997.3.387.
- Background: PubMed 10716544Jean-Louis G, Kripke DF, Ancoli-Israel S, Klauber MR, Sepulveda RS, Mowen MA, Assmus JD, Langer RD. Circadian sleep, illumination, and activity patterns in women: influences of aging and time reference. Physiol Behav. 2000 Jan;68(3):347-52. doi: 10.1016/s0031-9384(99)00186-9.
- Background: PubMed 10616229Jean-Louis G, von Gizycki H, Zizi F. Predictors of subjective sleepiness induced by melatonin administration. J Psychosom Res. 1999 Oct;47(4):355-8. doi: 10.1016/s0022-3999(98)00076-2.
- Background: PubMed 10565670Jean-Louis G, Mendlowicz MV, Von Gizycki H, Zizi F, Nunes J. Assessment of physical activity and sleep by actigraphy: examination of gender differences. J Womens Health Gend Based Med. 1999 Oct;8(8):1113-7. doi: 10.1089/jwh.1.1999.8.1113.
- Background: PubMed 10073464Jean-Louis G, Zizi F, von Gizycki H, Hauri P. Actigraphic assessment of sleep in insomnia: application of the Actigraph Data Analysis Software (ADAS). Physiol Behav. 1999 Jan 1-15;65(4-5):659-63. doi: 10.1016/s0031-9384(98)00213-3.
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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.
Daniel Kripke
University of California, San Diego
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Diseases and Heart Diseases, 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 29 Feb 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?
On the ClinicalTrials.gov record for NCT00005297, which also lists 8 linked publications.
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 29 Feb 2016.