Impact of Estrogen + Estradiol Receptor Alpha Modulator Therapy on Oxidative Stress in Post-menopausal Women With and Without Sleep Apnea

• Status: Unknown status
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

One of the most likely mechanisms explaining the sleep apnea (SA)-induced increase in metabolic syndrome is the oxidative stress (OS) induced by intermittent hypoxia (IH). There are clear-cut signs of OS in postmenopausal women that may be further enhanced by SA. In rats exposed to IH, an estradiol receptor alpha agonist decreases the level of OS markers. The aims of this study are to compare OS in apneic and non-apneic postmenopausal women and to demonstrate that OS will improve after 3 months of treatment with ER alpha agonists (Duavive) in apneic post-menopausal women.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laval University
• Collaborators: C Minville; C Rheaume; V Joseph
• Treatments: Bazedoxifene; Estradiol; Estrogens

Criteria

Inclusion Criteria:

• post-menopausal women

• aged 45 to 65 years

• BMI less/equal 35 kg.m-2,

• apnoea + hypopnea index (AHI) < 15/h (non SA group) or ≥ 30/h (SA group) on a polysomnographic recording,

• 90% of AHI associated with obstructive events,

• regular exercise, dietary and sleep habits

• free of sleep debt (insomnia, reported habitual sleep time > 6 h/night),

• stable medical condition.

Exclusion Criteria:

• clinically significant diurnal somnolence requiring immediate treatment in SA patients,

• nocturnal hypoventilation (% sleep time below 90% SaO2 > 10 %, PaCO2 > 45 mmHg),

• use of hormonal therapy,

• use of any medication with a respiratory depressant effect (narcotics),

• contraindication to the dug used in the protocol