Zolpidem on CPAP Acclimatization in OSA

Obstructive Sleep Apnea Clinical Trial

Official title:

The Effect of Zolpidem on CPAP Acclimatization in Patients With OSA: A Crossover, Randomized, Double-blinded, Placebo-controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06084130
• Other study ID #: 365/2566[IRB4]
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: October 15, 2023
• Est. completion date: October 15, 2024

Study information

• Verified date: October 2023
• Source: Siriraj Hospital
• Contact: Navarat Kasemsuk
• Phone: +66870890444
• Email: mintkus32[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Obstructive sleep apnea (OSA) is a sleep disorder characterized by a cessation or significant decrease in airflow during sleep. CPAP is the preferred therapy and has high effectiveness at all levels of OSA severity. It acts as a pneumatic splint to maintain upper airway patency during sleep, preventing the soft tissues from collapsing. However, the patient's compliance continues to be an issue. One of the main contributors to CPAP therapy failure is difficulty falling asleep. To aid in the machine's adaptation, hypnotic medicine was administered.

Description:

Obstructive sleep apnea (OSA) is a sleep disorder characterized by a cessation or significant decrease in airflow during sleep. According to a recent study, OSA may impact over 1 billion individuals worldwide. In Thailand, the prevalence of snoring in children is 6.9-8.5%, while the prevalence of OSA in children is 0.7-1.3%. Moreover, OSA affects 15.4% of Thai male adults and 6.3% of Thai females. Untreated OSA can lead to daytime sleepiness, decreased productivity, increased motor vehicle accidents, and worsening hypertension, atrial fibrillation, and stroke. Oral appliances, upper airway surgery, and continuous positive airway pressure (CPAP) devices are available as treatment alternatives.

CPAP is the preferred therapy and has high effectiveness at all levels of OSA severity. It acts as a pneumatic splint to maintain upper airway patency during sleep, preventing the soft tissues from collapsing. Through this mechanism, it effectively eliminates the apneas and/or hypopneas, decreases the arousals, and normalizes the oxygen saturation. However, the patient's compliance continues to be an issue. Failure of CPAP therapy may occur in up to 25% to 50% of patients, with patients typically discontinuing therapy within the first 2 to 4 weeks of treatment and 91% of patients discontinuing CPAP therapy within the first three years of therapy.

According to the clinical guidelines of the American Academy of Sleep Medicine, all potential PAP titration candidates should receive adequate PAP education, hands-on demonstration, careful mask fitting, and acclimatization prior to titration. Acclimatization is a technique used to familiarize patients with PAP therapy for compliance.

One of the main contributors to CPAP therapy failure is difficulty falling asleep. To aid in the machine's adaptation, hypnotic medicine was administered. Sedative medications now came in a variety of categories. Non-benzodiazepines sometimes referred to as Z-drugs, are among those with the beneficial characteristics of not deteriorating OSA severity, not contributing to drug addiction, possessing a rapid onset, and exhibiting fewer adverse consequences. Zolpidem, eszopiclone and zaleplon are included in this drug class. According to a previous meta-analysis, eszopiclone greatly facilitated the use of CPAP. However, up until now limited research on zolpidem and zaleplon was conducted. This study aims to evaluate the effect of zolpidem on CPAP compliance in OSA patients as compared to a placebo.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: October 15, 2024
• Est. primary completion date: October 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• OSA patients whose sleep test demonstrated apnea-hypopnea index (AHI) = 15 /hour or AHI = 5 /hour with comorbid disease including hypertension, cardiovascular disease, and stroke

• Age 18 to 75 years

• Indicated for CPAP therapy

• Naïve for the device usage

Exclusion Criteria:

• A history of zolpidem allergies

• Currently take hypnotic medications

• Denied permission to engage in the study and/or follow its protocol

• Individuals with liver diseases, including hepatitis from any cause, liver cirrhosis, and liver cancer

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Drug:
• Zolpidem
10 milligrams zolpidem contained in white-color opaque medicine capsule
• Placebo
corn-starch contained in identical white-color opaque medicine capsule

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Siriraj Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CPAP hour usage per night	CPAP hour usage per night in hours	on the end of the 1st as the 1st follow-up and the 2nd week as the 2nd follow-up
Secondary	Numbers of the patients with CPAP usage = 4 hours	Numbers of the patients with CPAP usage = 4 hours in persons	on the end of the 1st as the 1st follow-up and the 2nd week as the 2nd follow-up
Secondary	Number of the participants with % CPAP usage = 70	Number of the participants with % CPAP usage = 70 in persons	on the end of the 1st as the 1st follow-up and the 2nd week as the 2nd follow-up
Secondary	drug compliance, and adverse events	drug compliance with residual drug counts, and adverse events reports	on the end of the 1st as the 1st follow-up and the 2nd week as the 2nd follow-up