Lung DiseasesNCT00005525
Sleep Apnea in Elderly Male Twins
An observational study of Lung Diseases and Sleep Apnea Syndromes, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To conduct a genetic analysis of anatomic risk factors for sleep apnea in a well-characterized United States population-based registry of elderly male twins who have been successfully followed for the past 30 years. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Lung Diseases, Sleep Apnea Syndromes, Obesity
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Aug 1998to Jul 2002
- 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 conduct a genetic analysis of anatomic risk factors for sleep apnea in a well-characterized United States population-based registry of elderly male twins who have been successfully followed for the past 30 years.
Read the detailed description
BACKGROUND:
The contribution of genetic factors to sleep disorders has been demonstrated in twin and family studies, and further understanding of the genetic underpinning of sleep disorders is considered an important area of research. Many of the suggested risk factors for sleep apnea (e.g.,craniofacial morphology, obesity) have genetic determinants. However, a formal genetic analysis of these anatomical risk factors with sleep-recorded physiological measurements has not so far been conducted.
DESIGN NARRATIVE:
The investigators recruited a subsample of pairs from the NAS-NRC World War II Twin Registry in which at least one of the twin brothers reported sleep apnea symptoms and a subsample of control pairs in which both twins reported no symptoms. They monitoring the subgroup of twin pairs with overnight sleep recording. They also collected anthropometric measurements of weight, height, neck circumference, and craniofacial morphology and blood samples for determination of zygosity and DNA extraction for future molecular studies.
The twin design is most powerful for estimating the genetic and/or environmental overlap between physiological measurements such as sleep-recorded disordered breathing, obesity, and craniofacial morphology. The investigators chose to focus on an elderly male twin sample for which a wealth of data relevant to this study had been previously collected. Twin pair concordance or discordance for monitored sleep-disordered breathing allowed the full characterization of genetic/familial and individual environmental factors associated with the expression and severity of this condition.
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, Sleep Apnea Syndromes, Obesity
- Medical subject headings
- Lung Diseases, Sleep Apnea Syndromes, Obesity
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 startAug 1998
- Study completionJul 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Dorit Carmelli, SRI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005525
- Sponsor's protocol ID
- 5053
- Other IDs
- R01HL059659
- Status last verified
- Mar 2005
- First submitted
- 25 May 2000
- Last updated
- 16 Mar 2016
- Results posted
- No
Publications
Carmelli D, Bliwise DL, Swan GE, Reed T. A genetic analysis of the Epworth Sleepiness Scale in 1560 World War II male veteran twins in the NAS-NRC Twin Registry. J Sleep Res. 2001 Mar;10(1):53-8. doi: 10.1046/j.1365-2869.2001.00241.x.
PubMed 11285055Carmelli D, Bliwise DL, Swan GE, Reed T. Genetic factors in self-reported snoring and excessive daytime sleepiness: a twin study. Am J Respir Crit Care Med. 2001 Sep 15;164(6):949-52. doi: 10.1164/ajrccm.164.6.2012001.
PubMed 11587976Carmelli D, Colrain IM, Swan GE, Bliwise DL. Genetic and environmental influences in sleep-disordered breathing in older male twins. Sleep. 2004 Aug 1;27(5):917-22. doi: 10.1093/sleep/27.5.917.
PubMed 15453550
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
- Sleep Apnea in Elderly Male Twins
- ClinicalTrials.gov ID
- NCT00005525
- Acronym / sponsor ID
- 5053
- Conditions
- Lung Diseases, Sleep Apnea Syndromes, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Aug 1998
- Study completion
- Jul 2002 (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 conduct a genetic analysis of anatomic risk factors for sleep apnea in a well-characterized United States population-based registry of elderly male twins who have been successfully followed for the past 30 years.
Detailed description
BACKGROUND:
The contribution of genetic factors to sleep disorders has been demonstrated in twin and family studies, and further understanding of the genetic underpinning of sleep disorders is considered an important area of research. Many of the suggested risk factors for sleep apnea (e.g.,craniofacial morphology, obesity) have genetic determinants. However, a formal genetic analysis of these anatomical risk factors with sleep-recorded physiological measurements has not so far been conducted.
DESIGN NARRATIVE:
The investigators recruited a subsample of pairs from the NAS-NRC World War II Twin Registry in which at least one of the twin brothers reported sleep apnea symptoms and a subsample of control pairs in which both twins reported no symptoms. They monitoring the subgroup of twin pairs with overnight sleep recording. They also collected anthropometric measurements of weight, height, neck circumference, and craniofacial morphology and blood samples for determination of zygosity and DNA extraction for future molecular studies.
The twin design is most powerful for estimating the genetic and/or environmental overlap between physiological measurements such as sleep-recorded disordered breathing, obesity, and craniofacial morphology. The investigators chose to focus on an elderly male twin sample for which a wealth of data relevant to this study had been previously collected. Twin pair concordance or discordance for monitored sleep-disordered breathing allowed the full characterization of genetic/familial and individual environmental factors associated with the expression and severity of this condition.
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.
- Background: PubMed 11285055Carmelli D, Bliwise DL, Swan GE, Reed T. A genetic analysis of the Epworth Sleepiness Scale in 1560 World War II male veteran twins in the NAS-NRC Twin Registry. J Sleep Res. 2001 Mar;10(1):53-8. doi: 10.1046/j.1365-2869.2001.00241.x.
- Background: PubMed 11587976Carmelli D, Bliwise DL, Swan GE, Reed T. Genetic factors in self-reported snoring and excessive daytime sleepiness: a twin study. Am J Respir Crit Care Med. 2001 Sep 15;164(6):949-52. doi: 10.1164/ajrccm.164.6.2012001.
- Background: PubMed 15453550Carmelli D, Colrain IM, Swan GE, Bliwise DL. Genetic and environmental influences in sleep-disordered breathing in older male twins. Sleep. 2004 Aug 1;27(5):917-22. doi: 10.1093/sleep/27.5.917.
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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.
Dorit Carmelli
SRI International
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Diseases and Sleep Apnea Syndromes, 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?
On the ClinicalTrials.gov record for NCT00005525, which also lists 3 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 16 Mar 2016.