Zolpidem on CPAP Acclimatization in OSA

NCT06084130 | Unknown Phase 4

• 1 other identifier: 365/2566[IRB4]
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Numbers of the patients with CPAP usage ≥ 4 hours

  on the end of the 1st as the 1st follow-up and the 2nd week as the 2nd follow-up

• Number of the participants with % CPAP usage ≥ 70

  on the end of the 1st as the 1st follow-up and the 2nd week as the 2nd follow-up

• drug compliance, and adverse events

  on the end of the 1st as the 1st follow-up and the 2nd week as the 2nd follow-up

Study Arms (2)

Zolpidem

EXPERIMENTAL

The participants in Zolpidem group will receive 10 milligrams zolpidem contained in white-color opaque medicine capsule prepared by the pharmacist. The participants will be advised to take the medication 30 minutes prior to the bedtime until the 1-week follow up visit.

Drug: Zolpidem

Placebo

PLACEBO COMPARATOR

The participants in Placebo group will receive placebo which is corn-starch contained in identical white-color opaque medicine capsule. The participants will be advised to take the medication 30 minutes prior to the bedtime until the 1-week follow up visit.

Drug: Placebo

Interventions

Zolpidem DRUG

10 milligrams zolpidem contained in white-color opaque medicine capsule

Zolpidem

Placebo DRUG

corn-starch contained in identical white-color opaque medicine capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Siriraj Hospital: lead

Related Publications (1)

• Pisalnoradej P, Banhiran W, Kasemsuk N. The effect of zolpidem on CPAP acclimatization in patients with OSA: a crossover, randomized, double-blinded, placebo-controlled trial. J Clin Sleep Med. 2025 Nov 1;21(11):1831-1837. doi: 10.5664/jcsm.11850.

  PMID: 40790926 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Zolpidem

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Navarat Kasemsuk

CONTACT

+66870890444; mintkus32@hotmail.com

Piyakorn Pisalnoradej

CONTACT

+66818863677; piyakorn_pisalnoradej@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Placebo is corn-starch contained in identical white-color opaque medicine capsule to zolpidem
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Educator

Model Details: The eligible participants will be informed and consented. After then, the participants in group 1 will receive 10 milligrams zolpidem contained in white-color opaque medicine capsule prepared by the pharmacist, meanwhile the participants in group 2 will receive placebo which is corn-starch contained in identical white-color opaque medicine capsule. The participants will be advised to take the medication 30 minutes prior to the bedtime until the 1-week follow up visit. On the second week, the participants in group 1 will alternatively receive placebo, meanwhile the participants in group 2 will receive 10 milligrams zolpidem in identical capsules. The wash-out period is 24 hours as the fact that the half-life of zolpidem is 2 hours and total zolpidem elimination time is 10 to 12 hours.

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: October 16, 2023
• Study Start: October 15, 2023
• Primary Completion: October 15, 2024
• Study Completion: October 15, 2024
• Last Updated: October 16, 2023

Record last verified: 2023-10