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Sleep Apnea in Elderly

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ClinicalTrials.gov Identifier: NCT02703220
Recruitment Status : Recruiting
First Posted : March 9, 2016
Last Update Posted : October 17, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE January 29, 2016
First Posted Date  ICMJE March 9, 2016
Last Update Posted Date October 17, 2019
Actual Study Start Date  ICMJE July 3, 2015
Estimated Primary Completion Date December 2, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2016)
  • Apneic threshold- a measure of breathing instability [ Time Frame: 2 days to 30 days ]
    Measures of breathing instability including: Apneic threshold: this is the end-tidal Co2 at which a central apnea closes to a hypopnea is produced.
  • Cerebrovascular responsiveness to carbon-dioxide [ Time Frame: 7 days ]
    Cerebrovascular response to different levels of CO2: this is a measure of the response of the cerebral blood flow to changes in carbon dioxide levels and is used as a measure of ventilatory control of breathing
  • Ventilatory responsiveness [ Time Frame: 2 days to 30 days ]
    Hypocapnic ventilatory response; this is calculated as the change in minute ventilation for corresponding changes in PETCO2.
  • Carbon -dioxide reserve [ Time Frame: 2 days to 30 days ]
    This is a derived measure. This is calculated as the difference between the apneic threshold PETCO2 (given above) and the control PETCO2.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02703220 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2016)
Apnea hypopnea index [ Time Frame: 2 days to 30 days ]
Apnea hypopnea index- is a measure of severity of sleep apnea - this is calculated as the total number of apneas and hypopneas recorded during a sleep study divided by the total sleep time during the sleep study.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sleep Apnea in Elderly
Official Title  ICMJE Pathophysiology-Guided Therapy for Sleep Apnea in the Elderly
Brief Summary Sleep-disordered breathing (SDB or sleep apnea) is very common among elderly Veterans and leads to increased morbidity and mortality in this population. The proposal aims to identity whether oxygen, finasteride and acetazolamide can be effective in reducing unstable breathing and eliminating sleep apnea in the elderly via different mechanisms. This proposal will enhance the investigators' understanding of the pathways that contribute to the development of sleep apnea in the elderly. The investigators expect that the results obtained from this study will positively impact the health of Veterans by identifying new treatment modalities for sleep apnea. A cumulative effect of the investigators' research will fulfill the long-term goal of improving the quality of life of elderly Veterans suffering from sleep apnea and its potential life-threatening complications.
Detailed Description Sleep apnea-hypopnea syndrome (SAHS) has a high prevalence and is associated with adverse cardiovascular consequences in elderly Veterans. Positive airway pressure therapy is deemed cumbersome and often associated with non-adherence to therapy. This proposal will investigate whether alternative therapies can be developed by modulating specific physiologic mechanisms of ventilatory control. Specifically, the investigators will study whether interventions with sustained hyperoxia (Aim 1), finasteride (Aim 2) and acetazolamide (Aim 3) will reduce breathing instability during sleep by reducing chemoresponsiveness and/or increasing cerebrovascular reactivity (CVR) in order to alleviate sleep disordered breathing in the elderly with sleep apnea. The proposed aims will also allow us to delineate key mechanisms of breathing instability in the elderly. The investigators envision that the results obtained from this project will ultimately allow us to develop novel alternative therapies for sleep apnea in the elderly. We will also compare CVR in young vs older adults
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Other
Condition  ICMJE
  • Sleep Apnea
  • Elderly Adults
Intervention  ICMJE
  • Other: Hyperoxia/oxygen
    The ventilatory effects of brief hyperoxia will be assessed by analyzing control breaths on room air immediately preceding the hyperoxic exposure, and comparing with the primary end-point, nadir minute ventilation breath, immediately following the brief hyperoxic exposure
  • Drug: Acetazolamide
    Participants with sleep apnea will ingest capsules containing either placebo or acetazolamide 500 mg twice a day for 5 days. On the final 2 consecutive nights while still on ACZ, the investigators will perform i) physiology tests and ii) in-lab follow-up PSG.
  • Drug: Finasteride
    Elderly males with sleep apnea and adequate testosterone levels will ingest placebo vs finasteride, at 5 mg a day for 1 month (mo). After 1 mo, while still on the drug, on the final 2 consecutive nights, the investigators will perform i) physiology tests and ii) in-lab follow-up PSG. Blood tests will be performed to check sex hormone levels. A washout period of 1 month prior to cross-over to the alternate arm (placebo).
Study Arms  ICMJE
  • Experimental: Hyperoxia
    Determine the effect of sustained hyperoxia overnight vs room air overnight on ventilatory control during sleep, including the apneic threshold, carbon-dioxide reserve and chemosensitivity measured via pressure support ventilation (PSV) during (non-rapid eye movement sleep) NREM sleep.
    Intervention: Other: Hyperoxia/oxygen
  • Experimental: Acetazolamide (ACZ)
    Determine the effect of acetazolamide on cerebrovascular responsiveness to CO2 during wake and sleep. Participants will receive oral ACZ therapy for 7 days prior to the experimental night, on the night of the study and the subsequent night when polysomnography (PSG) will be performed.
    Intervention: Drug: Acetazolamide
  • Experimental: Finasteride
    Determine the effect of oral finasteride therapy vs placebo for 1 month on SDB and the AT and chemosensitivity during NREM sleep.
    Intervention: Drug: Finasteride
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 3, 2016)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2020
Estimated Primary Completion Date December 2, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adults who are 60 years old and older, with mild to moderate sleep apnea with AHI >/=5 to 20/hr with central, obstructive, mixed apneas and hypopneas.
  • For the finasteride protocol elderly men with above criteria will be enrolled.

Exclusion Criteria:

  • Patients with severe sleep apnea (AHI>20/hr)
  • Patients with history of prostate cancer
  • Males with hypogonadism
  • History of cardiac disease, including myocardial infarction
  • Bypass surgery
  • Atrial and ventricular tachy-bradycardias
  • Systolic congestive heart failure and Cheyne-Stokes respiration
  • Current unstable angina
  • Stroke
  • Schizophrenia
  • Untreated hypothyroidism
  • Seizure disorder
  • Preexisting renal failure and liver disorders
  • Failure to give informed consent.
  • Patients with significant pulmonary diseases by history and abnormal pulmonary function testing, including moderate obstructive/restrictive lung/chest wall disorders with resting oxygen saturation of <96% or on supplemental oxygen
  • Patients on certain medications including:

    • study drugs
    • sympathomimetics/parasympathomimetics or their respective blockers
    • narcotics
    • antidepressants
    • anti-psychotic agents
    • other central nervous system (CNS) altering medications
    • current alcohol, tobacco or recreational drug use
  • Patients with BMI>34kg/m2 will be excluded to avoid the effects of morbid obesity on pulmonary mechanics and ventilatory control
  • Elderly with unstable gait or mobility issues that may preclude safe participation
  • Individuals with allergy to finasteride or acetazolamide will be excluded from the specific protocol
  • Pregnant women
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Gender Eligibility Description: The Finasteride arm of the study is only applicable for male gender.
Ages  ICMJE 60 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Ruchi Rastogi, MSc (313) 576-1000 rrastogi@med.wayne.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02703220
Other Study ID Numbers  ICMJE PULM-008-14F
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Susmita Chowdhuri, MD John D. Dingell VA Medical Center, Detroit, MI
PRS Account VA Office of Research and Development
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP