Sleep and Breathing in the General Population - Chemical Stimuli

NCT04720547 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: 12030107495R01HL130552-05
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep-disordered Breathing

Keywords

Sleep-disordered Breathing; central sleep apnea

Outcome Measures

Primary Outcomes (2)

• The Central Apnea-hypopnea Index

  The number of central apneas and hypopneas per hour of sleep was obtained from polysomnography studies.

  one night

• Respiratory Arousal Index

  A measure of the frequency of respiratory-related arousals during sleep

  one night

Secondary Outcomes (4)

• CO2 Reserve

  one night

• Controller Gain

  one night

• Stead-State Plant Gain (mmHg

  one night

• Respiratory Arousal Threshold

  one night

Study Arms (2)

Zolpidem, then No Treatment

EXPERIMENTAL

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

Drug: Zolpidem; Other: No Treatment

No Treatment, then Zolpidem

EXPERIMENTAL

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

Drug: Zolpidem; Other: No Treatment

Interventions

Zolpidem DRUG

A nonbenzodiazepine hypnotic

Also known as: Ambien

No Treatment, then Zolpidem; Zolpidem, then No Treatment

No Treatment OTHER

The Control condition in which participants do not receive medication.

No Treatment, then Zolpidem; Zolpidem, then No Treatment

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wayne State University: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

John D. Dingell VA Medical Center

Detroit, Michigan, 48201, United States

Location

Related Publications (1)

• 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.

  PMID: 35286569 DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Apnea, Central

Interventions

Zolpidem

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Abdulghani Sankari
• Organization: Wayne State University

atarbich@med.wayne.edu

313-576-3548

Study Officials

• M Safwan Badr, MD, MBA

  John D. Dingell VA Medical Center, Detroit, MI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Personnel conducting assessment of outcomes and data analysis are blinded to treatment.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of Internal Medicine

Model Details: 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.

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: January 22, 2021
• Study Start: July 3, 2018
• Primary Completion: February 29, 2020
• Study Completion: February 29, 2020
• Last Updated: December 6, 2023
• Results First Posted: April 28, 2022

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)