Sleep ApneaNCT00732199
Determinants of Age Related Breathing Instability During Non-Rapid-Eye-Movement (NREM) Sleep
A study testing 1) hyperventilation via noninvasive positive pressure ventilation 2) multiple trials of episodic hypoxia in people with Sleep Apnea and Age, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The purpose for this research protocol was to examine the role of breathing control mechanisms that determine the development of sleep-disordered breathing in the elderly. This proposal focused on key factors that contribute to the control of ventilation in elderly adults during sleep. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea, Age
- What is being tested?
- 1) hyperventilation via noninvasive positive pressure ventilation 2) multiple trials of episodic hypoxia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Apr 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy older and young adults
Who cannot join
- Pregnancy,
- history of active coronary artery disease-including stable and unstable angina,
- recent myocardial infarction,
- history of congestive heart failure,
- stroke,
- excessive daytime sleepiness with Epworth Sleepiness Scale of >15
Show all 19Show fewer
- patient with OSA- (Obstructive sleep apnea) on therapy
- depression,
- schizophrenia,
- untreated hypothyroidism,
- diabetes on insulin,
- seizure disorder,
- intrinsic renal and liver disorders,
- failure to give informed consent,
- patients with evidence of pulmonary diseases based on history and abnormal pulmonary function testing, including obstructive (ratio of predicted forced expiratory volume to forced vital capacity, <80% predicted) or restrictive lung disorders (total lung capacity <80% predicted) with resting oxygen saturation of <96% and kyphoscoliosis (chest wall deformities)
- patients on certain medications including, opiates derivatives, stimulants, antidepressants, tranquilizers, anti-psychotic agents, theophylline and other central nervous system altering medications
- history of alcohol or recreational drug use will also serve as grounds for exclusion,
- patients with body mass index (BMI) >34kg/m2
- subjects with sleep apnea are already using continuous positive airway pressure for more than 7 days as therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
John D. Dingell VA Medical Center, Detroit, MI
Detroit, Michigan, 48201
About this study
Official title: Determinants of Age-specific Breathing Instability During Sleep
The purpose for this research protocol was to examine the role of breathing control mechanisms that determine the development of sleep-disordered breathing in the elderly. This proposal focused on key factors that contribute to the control of ventilation in elderly adults during sleep. The investigators studied the age-specific changes in ventilatory control in older and young adults during NREM sleep.
Read the detailed description
Sleep apnea-hypopnea syndrome (SAS) is a relatively common disorder in the US population with significant adverse health consequences. Despite the high prevalence of SAS in elderly individuals, the underlying mechanisms have remained elusive. Specifically, the investigators do not know whether the high prevalence of sleep apnea in older adults is due to increased central breathing instability. This proposal focused on investigating age-specific differences in the susceptibility to central breathing instability in adults.
This project had the following specific objectives:
- To determine age-specific changes in the hypocapnic apneic threshold during NREM sleep in elderly vs young individuals.
- To determine age-specific changes in long-term facilitation during sleep in elderly versus young individuals.
Procedure: The investigators determined the susceptibility to central breathing instability by mechanically ventilating the subjects during NREM sleep using non-invasive pressure support ventilation. The investigators compared the hypocapnic apneic threshold in old (age>60 years) and young (age 18-50 years) individuals who were healthy. The investigators also measured the parameters over a continuum of age from 18 to 89 years.
- The investigators investigated whether there was a difference in the susceptibility to long term facilitation of ventilation between young and old healthy individuals in response to episodic hypoxia, while maintaining isocapnia.
Sleep apnea is very common in older Veterans and is associated with significant cardiovascular complications. Greater insight into the pathogenesis will have a positive impact on the health of Veterans suffering from this condition. This study furthers the understanding of the pathogenesis of breathing instability leading to sleep-disordered breathing during sleep. The investigators anticipate findings will provide a basis for new approaches to prevention and management of SAS in Veterans.
- Conditions
- Sleep Apnea, Age
- Being tested
- 1) hyperventilation via noninvasive positive pressure ventilation 2) multiple trials of episodic hypoxia
- Keywords
- apneic threshold, central apnea, intermittent hypoxia, aging, ventilation, chemoresponsiveness, carbon-dioxide reserve
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Central, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1) hyperventilation via noninvasive positive pressure ventilation 2) multiple trials of episodic hypoxiaOther
- noninvasive hyperventilation to determine apneic threshold; 2) episodic hypoxia to determine ventilatory long term facilitation
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Determine the apneic threshold and carbon- dioxide reserve using noninvasive positive pressure ventilation during NREM sleep and determine the effect effect of episodic hypoxia on ventilatory long-term facilitation during NREM sleep in Young adults. Receives: Other: 1) hyperventilation via noninvasive positive pressure ventilation 2) multiple trials of episodic hypoxia |
| Arm 2 | Experimental | Determine the apneic threshold and carbon- dioxide reserve using noninvasive positive pressure ventilation during NREM sleep and determine the effect of episodic hypoxia on ventilatory long-term facilitation during NREM sleep in Older adults. Receives: Other: 1) hyperventilation via noninvasive positive pressure ventilation 2) multiple trials of episodic hypoxia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apneic Threshold (AT) and Carbon-dioxide (CO2) Reserve
The AT was defined as the end-tidal (PETCO2) that demarcated the central apnea closest to the eupneic PETCO2. The CO2 reserve was defined as the difference in PETCO2 between eupnea and AT.
Measured: 4-6 wks for each participant
Long-term Facilitation (LTF) of Ventilation, Minute Ventilation Was Measured in Older Adults Only
Episodic hypoxia (EH) leads to sustained elevation of the ventilatory motor output, referred to as LTF, an excitatory mechanism characterized by a sustained elevation in ventilatory motor output following EH. Minute ventilation during recovery period after multiple trials of EH. This is reported in older adults on this grant.
Measured: 4-6 wks for each participant
Secondary outcomes (2)
Hypoxic Ventilatory Response
Hypoxic ventilatory response was calculated as the change in minuted ventilation for a change in oxygen saturation during each hypoxia trial.
Measured: 4-6 wks for each participant
Brief Hyperoxia Response
Brief hyperoxia response was the nadir minute ventilation achieved immediately upon exposure to brief hyperoxia expressed as a percent of eupneic minuted ventilation.
Measured: 4-6 wks for each participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2008 (estimated)
- Study startOct 2008
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Susmita Chowdhuri, MD, Principal investigator, John D. Dingell VA Medical Center, Detroit, MI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00732199
- Sponsor's protocol ID
- CDA-2-019-07F
- Status last verified
- Apr 2017
- First submitted
- 7 Aug 2008
- Last updated
- 28 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Chowdhuri S, Pranathiageswaran S, Franco-Elizondo R, Jayakar A, Hosni A, Nair A, Badr MS. Effect of age on long-term facilitation and chemosensitivity during NREM sleep. J Appl Physiol (1985). 2015 Nov 15;119(10):1088-96. doi: 10.1152/japplphysiol.00030.2015. Epub 2015 Aug 27.
PubMed 26316510
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Age-specific Breathing Instability During Sleep
- ClinicalTrials.gov ID
- NCT00732199
- Acronym / sponsor ID
- CDA-2-019-07F
- Conditions
- Sleep Apnea, Age
- Keywords
- apneic threshold, central apnea, intermittent hypoxia, aging, ventilation, chemoresponsiveness, carbon-dioxide reserve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Oct 2008
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 11 Aug 2008 (estimated)
- Results
- Posted 28 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose for this research protocol was to examine the role of breathing control mechanisms that determine the development of sleep-disordered breathing in the elderly. This proposal focused on key factors that contribute to the control of ventilation in elderly adults during sleep. The investigators studied the age-specific changes in ventilatory control in older and young adults during NREM sleep.
Detailed description
Sleep apnea-hypopnea syndrome (SAS) is a relatively common disorder in the US population with significant adverse health consequences. Despite the high prevalence of SAS in elderly individuals, the underlying mechanisms have remained elusive. Specifically, the investigators do not know whether the high prevalence of sleep apnea in older adults is due to increased central breathing instability. This proposal focused on investigating age-specific differences in the susceptibility to central breathing instability in adults.
This project had the following specific objectives:
- To determine age-specific changes in the hypocapnic apneic threshold during NREM sleep in elderly vs young individuals.
- To determine age-specific changes in long-term facilitation during sleep in elderly versus young individuals.
Procedure: The investigators determined the susceptibility to central breathing instability by mechanically ventilating the subjects during NREM sleep using non-invasive pressure support ventilation. The investigators compared the hypocapnic apneic threshold in old (age>60 years) and young (age 18-50 years) individuals who were healthy. The investigators also measured the parameters over a continuum of age from 18 to 89 years.
- The investigators investigated whether there was a difference in the susceptibility to long term facilitation of ventilation between young and old healthy individuals in response to episodic hypoxia, while maintaining isocapnia.
Sleep apnea is very common in older Veterans and is associated with significant cardiovascular complications. Greater insight into the pathogenesis will have a positive impact on the health of Veterans suffering from this condition. This study furthers the understanding of the pathogenesis of breathing instability leading to sleep-disordered breathing during sleep. The investigators anticipate findings will provide a basis for new approaches to prevention and management of SAS in Veterans.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Other: 1) hyperventilation via noninvasive positive pressure ventilation 2) multiple trials of episodic hypoxiaDetermine the apneic threshold and carbon- dioxide reserve using noninvasive positive pressure ventilation during NREM sleep and determine the effect effect of episodic hypoxia on ventilatory long-term facilitation during NREM sleep in Young adults. |
| Arm 2 | Experimental | Other: 1) hyperventilation via noninvasive positive pressure ventilation 2) multiple trials of episodic hypoxiaDetermine the apneic threshold and carbon- dioxide reserve using noninvasive positive pressure ventilation during NREM sleep and determine the effect of episodic hypoxia on ventilatory long-term facilitation during NREM sleep in Older adults. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy older and young adults
Key exclusion criteria (19 listed)
- Pregnancy,
- history of active coronary artery disease-including stable and unstable angina,
- recent myocardial infarction,
- history of congestive heart failure,
- stroke,
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 |
|---|---|---|
| 1) hyperventilation via noninvasive positive pressure ventilation 2) multiple trials of episodic hypoxia1) noninvasive hyperventilation to determine apneic threshold; 2) episodic hypoxia to determine ventilatory long term facilitation | Other | Arm 1, Arm 2 |
Primary outcome
Apneic Threshold (AT) and Carbon-dioxide (CO2) Reserve
Time frame: 4-6 wks for each participant
The AT was defined as the end-tidal (PETCO2) that demarcated the central apnea closest to the eupneic PETCO2. The CO2 reserve was defined as the difference in PETCO2 between eupnea and AT.
Long-term Facilitation (LTF) of Ventilation, Minute Ventilation Was Measured in Older Adults Only
Time frame: 4-6 wks for each participant
Episodic hypoxia (EH) leads to sustained elevation of the ventilatory motor output, referred to as LTF, an excitatory mechanism characterized by a sustained elevation in ventilatory motor output following EH. Minute ventilation during recovery period after multiple trials of EH. This is reported in older adults on this grant.
2 secondary outcomes
Hypoxic Ventilatory Response
Time frame: 4-6 wks for each participant
Brief Hyperoxia Response
Time frame: 4-6 wks for each participant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26316510Chowdhuri S, Pranathiageswaran S, Franco-Elizondo R, Jayakar A, Hosni A, Nair A, Badr MS. Effect of age on long-term facilitation and chemosensitivity during NREM sleep. J Appl Physiol (1985). 2015 Nov 15;119(10):1088-96. doi: 10.1152/japplphysiol.00030.2015. Epub 2015 Aug 27.
- Individual participant dataSharing planned: No
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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.
Susmita Chowdhuri, MD principal investigator
John D. Dingell VA Medical Center, Detroit, MI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1) hyperventilation via noninvasive positive pressure ventilation 2) multiple trials of episodic hypoxia in people with Sleep Apnea and Age, run by VA Office of Research and Development at 1 site in United States.
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 19 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 28 Jun 2017. 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 United States. 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?
Yes. Results are posted in the registry (first posted 28 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Apneic Threshold (AT) and Carbon-dioxide (CO2) Reserve (time frame: 4-6 wks for each participant). The study lists 2 primary outcomes in all. 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 NCT00732199, 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 28 Jun 2017.