Obstructive Sleep ApneaPhase 4NCT06084130
Zolpidem on CPAP Acclimatization in OSA
A Phase 4 study testing Zolpidem in people with Obstructive Sleep Apnea, run by Siriraj Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Zolpidem
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2023to 15 Oct 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Zolpidem on CPAP Acclimatization in Patients With OSA: A Crossover, Randomized, Double-blinded, Placebo-controlled Trial
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.
Read the detailed 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Zolpidem, Placebo
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZolpidemDrug
10 milligrams zolpidem contained in white-color opaque medicine capsule
PlaceboDrug
corn-starch contained in identical white-color opaque medicine capsule
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPAP hour usage per night
CPAP hour usage per night in hours
Measured: 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
Numbers of the patients with CPAP usage ≥ 4 hours in persons
Measured: 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
Number of the participants with % CPAP usage ≥ 70 in persons
Measured: 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
drug compliance with residual drug counts, and adverse events reports
Measured: on the end of the 1st as the 1st follow-up and the 2nd week as the 2nd follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start15 Oct 2023 (estimated)
- Primary completion15 Oct 2024 (estimated)
- Study completion15 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Siriraj Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Navarat Kasemsuk, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06084130
- Sponsor's protocol ID
- 365/2566[IRB4]
- Status last verified
- Oct 2023
- First submitted
- 28 Sep 2023
- Last updated
- 16 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40790926
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Zolpidem on CPAP Acclimatization in Patients With OSA: A Crossover, Randomized, Double-blinded, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT06084130
- Acronym / sponsor ID
- 365/2566[IRB4]
- Conditions
- Obstructive Sleep Apnea
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Study start
- 15 Oct 2023 (estimated)
- Primary completion
- 15 Oct 2024 (estimated)
- Study completion
- 15 Oct 2024 (estimated)
- First posted
- 16 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Zolpidem | Experimental | Drug: ZolpidemThe 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. |
| Placebo | Placebo comparator | Drug: PlaceboThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zolpidem10 milligrams zolpidem contained in white-color opaque medicine capsule | Drug | Zolpidem |
| Placebocorn-starch contained in identical white-color opaque medicine capsule | Drug | Placebo |
Primary outcome
CPAP hour usage per night
Time frame: on the end of the 1st as the 1st follow-up and the 2nd week as the 2nd follow-up
CPAP hour usage per night in hours
3 secondary outcomes
Numbers of the patients with CPAP usage ≥ 4 hours
Time frame: 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
Time frame: 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
Time frame: on the end of the 1st as the 1st follow-up and the 2nd week as the 2nd follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
- Derived from this study: PubMed 40790926Pisalnoradej 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zolpidem in people with Obstructive Sleep Apnea, run by Siriraj Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Navarat Kasemsuk (+66870890444, mintkus32@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CPAP hour usage per night (time frame: on the end of the 1st as the 1st follow-up and the 2nd week as the 2nd follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06084130, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2023.