Nasal spray treatment lessens sleep apnea severity in select patients

Key takeaways:

• Patients with improved upper airway collapsibility after BAY2586116 nasal spray use also saw a reduction in sleep apnea severity.
• These patients had lower morning blood pressure with BAY2586116 vs. placebo.

Patients with obstructive sleep apnea who achieved upper airway collapsibility improvement with a drug administered via nasal spray also had lower disease severity after use of the spray, according to study results.

As Healio previously reported, BAY2586116 (Bayer) nasal spray, a TWIK-related acid sensitive K+ (TASK) 1/3 channel antagonist, improved upper airway collapsibility.

Amal M. Osman

“We do not have approved pharmacotherapy for sleep apnea available clinically,” Amal M. Osman, PhD, postdoctoral research associate at Flinders University, told Healio. “If shown to be safe and effective in larger, longer-term trials, this nasal spray could be a standalone therapeutic option for certain people with OSA or an adjunct therapy for people who are incomplete responders to existing OSA therapies.”

In a randomized, blinded trial published in American Journal of Physiology Heart and Circulatory Physiology, Osman and colleagues evaluated 10 patients (50% women; mean age, 59 years) with OSA who previously participated in studies involving BAY2586116 to find out if the drug lowers disease severity.

This crossover trial consisted of three polysomnography studies, during which researchers randomly gave patients 160 µg of BAY2586116, 160 µg of BAY2586116 restricted to nasal breathing via a chinstrap/mouth tape or placebo saline spray. Approximately 1 week passed between each study, and every patient received each of the treatment options once.

Researchers classified patients who achieved upper airway collapsibility improvement with the nasal spray in a previous study as physiological responders (n = 5).

Patients receiving BAY2586116 did not report any serious drug-related adverse events.

Even though the unrestricted breathing BAY2586116 treatment was linked to decreased apnea-hypopnea index with 3% or greater oxygen desaturation (AHI3) scores in seven patients, changes in AHI3 did not significantly differ between the placebo group and the unrestricted breathing BAY2586116 group or the nasal-breathing BAY2586116 group.

Further, researchers did not find significant differences between groups when assessing AHI4, oxygen desaturation index (ODI) and other OSA severity measures.

“We were somewhat surprised that the restricted nasal breathing (using a mouth tape and/or chinstrap) condition did not yield reductions in OSA severity with the nasal spray as expected,” Osman told Healio. “However, this gave us new insight into how the use of a chinstrap may worsen the airway (by moving the jaw back).”

In the physiological responder subgroup, researchers found significantly lower OSA severity among patients who received BAY2586116 with unrestricted breathing vs. placebo as assessed through various measures:

• AHI3 (28 events/hour vs. 36 events/hour);
• AHI4 (15 events/hour vs. 22 events/hour);
• ODI for at least 3% desaturation (18 events/hour vs. 28 events/hour);
• ODI for at least 4% desaturation (12 events/hour vs. 18 events/hour);
• rapid eye movement (REM) AHI3 (40 events/hour vs. 52 events/hour);
• non-REM AHI4 (11 events/hour vs. 18 events/hour);
• non-REM ODI3 (13 events/hour vs. 24 events/hour); and
• non-REM ODI4 (7 events/hour vs. 14 events/hour).

Between the unrestricted breathing BAY2586116 group and the placebo group, responders receiving BAY2586116 had significant increases in mean oxygen saturation (95.2% vs. 94%) and non-REM oxygen saturation (95.4% vs. 94.6%), as well as a significant 26% decrease in non-REM hypoxic burden and a significant 28% decrease in REM hypoxic burden.

Researchers additionally noted that patients from this subgroup receiving BAY2586116 vs. placebo had greater decreases in systolic blood pressure (137 mmHg vs. 147 mmHg; P = .005) and diastolic blood pressure (82 mmHg vs. 91 mmHg; P = .04) measured in the morning.

When compared with placebo, responder patients receiving BAY2586116 with nasal breathing only did not demonstrate significant improvements in the above measures.

Researchers also found no significant differences between the placebo and BAY2586116 groups in the nonresponder cohort.

“It would be interesting to study the effects of a higher dose of this nasal spray on sleep apnea severity and longer-term studies that include people with less severe OSA,” Osman said.

Reference:

• Sleep apnea solution could be right under your nose. https://news.flinders.edu.au/blog/2024/03/15/sleep-apnea-solution-could-be-right-under-your-nose/. Published March 15, 2024. Accessed March 19, 2024.