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Sleep and Breathing in the General Population - Chemical Stimuli

NCT ID: NCT04720547

Last Updated: 2023-12-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-03

Study Completion Date

2020-02-29

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Sleep-disordered Breathing

Keywords

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Sleep-disordered Breathing central sleep apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

After an initial assessment to determine eligibility, participant complete two in-lab night studies in a randomized manner including one night with the administration of zolpidem and another without zolpidem.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Personnel conducting assessment of outcomes and data analysis are blinded to treatment.

Study Groups

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Zolpidem, then No Treatment

Participants will be administered zolpidem for the first night study, and No Treatment during the second night study.

Group Type EXPERIMENTAL

Zolpidem

Intervention Type DRUG

A nonbenzodiazepine hypnotic

No Treatment

Intervention Type OTHER

The Control condition in which participants do not receive medication.

No Treatment, then Zolpidem

Participants will be administered zolpidem for the second night study, and No Treatment during the first night study.

Group Type EXPERIMENTAL

Zolpidem

Intervention Type DRUG

A nonbenzodiazepine hypnotic

No Treatment

Intervention Type OTHER

The Control condition in which participants do not receive medication.

Interventions

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Zolpidem

A nonbenzodiazepine hypnotic

Intervention Type DRUG

No Treatment

The Control condition in which participants do not receive medication.

Intervention Type OTHER

Other Intervention Names

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Ambien

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Wayne State University

OTHER

Sponsor Role lead

Responsible Party

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M Safwan Badr

Chair of Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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M Safwan Badr, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

John D. Dingell VA Medical Center, Detroit, MI

Locations

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John D. Dingell VA Medical Center

Detroit, Michigan, United States

Site Status

Countries

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United States

References

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Ahmad B, Sankari A, Eshraghi M, Aldwaikat A, Yarandi H, Zeineddine S, Salloum A, Badr MS. Effect of Zolpidem on nocturnal arousals and susceptibility to central sleep apnea. Sleep Breath. 2023 Mar;27(1):173-180. doi: 10.1007/s11325-022-02593-3. Epub 2022 Mar 14.

Reference Type DERIVED
PMID: 35286569 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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5R01HL130552-05

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1203010749

Identifier Type: -

Identifier Source: org_study_id