N/A
N=92
Determinants of Age Related Breathing Instability During Non-Rapid-Eye-Movement (NREM) Sleep
Sleep Apnea · Age
Bottom Line
View on ClinicalTrials.gov: NCT00732199 ↗Enrolled (actual)
92
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Apneic Threshold (AT) and Carbon-dioxide (CO2) Reserve — 39.8; 36.7; -4.1; -2.6 mm Hg — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 1) hyperventilation via noninvasive positive pressure ventilation 2) multiple trials of episodic hypoxia (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Apneic Threshold (AT) and Carbon-dioxide (CO2) Reserve |
39.8; 36.7; -4.1; -2.6 | <0.05 sig |
| PRIMARY Long-term Facilitation (LTF) of Ventilation, Minute Ventilation Was Measured in Older Adults Only |
94.4 | <0.05 sig |
| SECONDARY Hypoxic Ventilatory Response |
0.21; 0.53 | <0.05 sig |
| SECONDARY Brief Hyperoxia Response |
89.7; 79.6 | <0.05 sig |
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. The investigators studied the age-specific changes in ventilatory control in older and young adults during NREM sleep.
Eligibility Criteria
Inclusion Criteria
- Healthy older and young adults
Exclusion Criteria
- 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
- 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, 34kg/m2
- subjects with sleep apnea are already using continuous positive airway pressure for more than 7 days as therapy
Data sourced from ClinicalTrials.gov (NCT00732199). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.