Sleep and Breathing in the General Population - Chemical Stimuli

Sleep-disordered Breathing Clinical Trial

Official title:

Sleep and Breathing in Health and Disease (Part 2A - Chemical Stimuli, Sleep and Breathing in the General Population)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04720547
• Other study ID #: 1203010749
• Secondary ID: 5R01HL130552-05
• Status: Completed
• Phase: Phase 4
• Start date: July 3, 2018
• Est. completion date: February 29, 2020

Study information

• Verified date: December 2023
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Central sleep apnea (CSA) is a common condition and its treatment remains elusive. The focus of this proposal is to identify the role of the physiologic path involving cortical arousals in CSA by decreasing arousal frequency using the pharmacological agent zolpidem. The goal is to identify the acute effects of administering zolpidem on sleep and respiratory outcomes, and subsequently, its effect on the severity of CSA and propensity to develop CSA. This study will shed light on the mechanisms underlying CSA that involve cortical arousals and will guide future therapeutic interventions for CSA.

Description:

The literature suggests that zolpidem may be effective in the treatment of central sleep apnea (CSA). However, evidence regarding the efficacy of zolpidem and the underlying mechanisms involved in its effect on CSA are not well-studied. Furthermore, respiratory-related arousals are hypothesized to contribute CSA symptoms and severity. The aim of the study is to determine the effect of decreasing respiratory-related arousals on the propensity to develop central apnea. The investigators hypothesize that administration of the nonbenzodiazepine hypnotic zolpidem will decrease the frequency of respiratory-related arousals, lower the central apnea-hypopnea index, and widen the CO2 reserve during sleep in patients with CSA compared to no treatment. Participants will complete a night study on a low dose of zolpidem and another night study without zolpidem in a crossover manner. The order of night studies is randomized. The results will help unveil the role of arousals in CSA and the acute effect of zolpidem on CSA severity and the propensity to CSA.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: February 29, 2020
• Est. primary completion date: February 29, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

• Men and women Veterans with central sleep apnea, defined as Apnea Hypopnea Index (AHI)>15/hour with CAHI>5/hour, will be included in the experiments.

Exclusion Criteria:

• less than 18 years old

• pregnant or breastfeeding female

• have severe respiratory disease that require to be on oxygen

• recent health event that may affect the ability to participate in the study,

• Body Mass Index (BMI) is >40 kg/m2

• significant insomnia

• mental instability

• recent health event that may affect sleep

• if at any time the principal investigator (PI) identifies that a certain drug is not suitable, or are unable to use the device that is used to treat sleep apnea, will be not be allowed to participate in the study

Related Conditions & MeSH terms

• Respiratory Aspiration
• Sleep Apnea Syndromes
• Sleep-disordered Breathing

Intervention

Drug:
• Zolpidem
A nonbenzodiazepine hypnotic

Other:
• No Treatment
The Control condition in which participants do not receive medication.

Locations

Country	Name	City	State
United States	John D. Dingell VA Medical Center	Detroit	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
Wayne State University	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Central Apnea-hypopnea Index	The number of central apneas and hypopneas per hour of sleep was obtained from polysomnography studies.	one night
Primary	Respiratory Arousal Index	A measure of the frequency of respiratory-related arousals during sleep	one night
Secondary	CO2 Reserve	CO2 reserve is the requisite change to induce central apnea is referred to as the CO2 reserve, which can be positive or negative. CO2 reserve is defined as the difference between the eupneic end-tidal CO2 pressure and the end-tidal CO2 pressure induced by the ventilation protocol that is sufficient to trigger a central apnea as defined by the American Academy of Sleep Medicine.	one night
Secondary	Controller Gain	Controller gain is a ventilatory response to changes in end-tidal PCO2. Controller gain was calculated by dividing the difference in minute ventilation between the post-mechanical ventilation induced by the ventilation protocol and steady-state respiration by the difference in the end-tidal CO2 pressure between the mechanical ventilation and steady-state respiration.	one night
Secondary	Stead-State Plant Gain (mmHg	Plant gain is a blood gas response to a change in ventilation. This measure represents the effectiveness of the "plant" in eliminating CO2. Steady-state plant gain was calculated from the ratio of end-tidal CO2 to minute ventilation during stable respiration.	one night
Secondary	Respiratory Arousal Threshold	The nadir pressure in the upper airway (supra-glottic pressure) prior to the occurrence of an arousal	one night